[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Edwards Lifesciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":437},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,40,64,89,111,132,169,193,214,240,265,296,315,336,358,383,405],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100602172","real-world-data-collection-on-the-inspiris-resilia-aortic-valve-100602172",false,"NCT07120048","Real World Data Collection on the INSPIRIS RESILIA Aortic Valve","A Prospective, Observational Registry Study Designed to Collect Real-world Hemodynamic and Clinical Outcomes of the INSPIRIS RESILIA Aortic Valve","INDICATE","Inclusion Criteria:\n\n1. Patients requiring an aortic valve replacement using the INSPIRIS RESILIA aortic valve according to its intended purpose\n2. Patients with standard-of-care pre-procedure imaging evaluation (echocardiography and CT) data available\n3. Age ≥ 18 years\n4. Provision of written informed consent\n\nExclusion Criteria:\n\n1. Active endocarditis\u002Fmyocarditis or endocarditis\u002Fmyocarditis within 3 months prior to the scheduled aortic valve replacement surgery\n2. Emergency procedure\n3. Patients requiring a non-aortic heart valve procedure during the index procedure","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","3 Months","OBSERVATIONAL","Collect real-world data on hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A, in subjects requiring replacement of their native or prosthetic aortic valve as the only heart valve procedure during the index procedure, with or without other concomitant procedures.",[26],"Aortic Valve Disease","RECRUITING","2026-06-18",{"date":30,"type":31},"2026-06-22","ACTUAL",{"date":33,"type":31},"2025-07-30",{"date":35,"type":21},"2026-12",{"name":37,"class":38},"Edwards Lifesciences","INDUSTRY",14,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100609591","the-continuity-study-100609591","NCT07216573","The Continuity Study","Continuous Blood Pressure Monitoring During Outpatient Surgery","Inclusion Criteria:\n\n1. Signed informed consent\n2. Age ≥ 18 years\n3. American Society of Anesthesiologists (ASA) Physical Status ≥ 2\n4. Scheduled for elective noncardiac surgery with intermittent arterial blood pressure monitoring using oscillometric arm cuff\n\nExclusion Criteria:\n\n1. Patient who is known to be pregnant\n2. Patient with existing or planned arterial pressure catheter\n3. Patient in whom systolic arterial pressure differs by more than 20 mmHg between the right and left arms\n4. Inability to place oscillometric cuff on the subject's upper extremity\n5. Extreme contraction of the smooth muscle in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease\n6. Finger or hand deformity that prevents proper placement of finger cuff by visual inspection\n7. Inability to place finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)",{"count":48,"type":21},188,"INTERVENTIONAL",[51],"NA","A before and after interventional cohort study comparing intermittent blood pressure measurement using the oscillometric arm cuff to continuous noninvasive blood pressure (cNIBP) measurement using the VitaWave finger cuffs in subjects undergoing elective surgery in an outpatient setting.",[54],"Blood Pressure","2026-06-03",{"date":57,"type":31},"2026-06-04",{"date":59,"type":31},"2026-05-07",{"date":61,"type":21},"2027-02",{"name":37,"class":38},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":49,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100369961","edwards-pascal-transcatheter-valve-repair-system-pivotal-clinical-trial-100369961","NCT04097145","Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial","A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation","CLASP II TR","Inclusion Criteria:\n\n* Eighteen (18) years of age or older\n* Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.\n* Severe or greater tricuspid regurgitation\n* New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months\n* Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team\n* Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements\n\nExclusion Criteria:\n\n* Tricuspid valve anatomy not evaluable by TTE or TEE\n* Tricuspid valve anatomy precludes proper device deployment and function\n* Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC\u002FAHA Stage D heart failure)\n* Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:\n\n  1. Would prevent proper TR reduction due to interaction of the lead with the leaflets\n  2. Were implanted in the RV within the last 90 days prior to the point of enrollment\n* Primary non-degenerative tricuspid disease\n* Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL\n* Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction\n* Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment\n* Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days\n* Recent Stroke\n* Active gastrointestinal (GI) bleeding\n* Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease, including but not limited to atrial septal defect, RV dysplasia, and arrhythmogenic RV\n* Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days\n* Any of the following cardiovascular procedures:\n\n  1. Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment\n  2. Carotid surgery within 30 days prior to the point of enrollment\n  3. Direct current cardioversion within the last 30 days prior to the point of enrollment\n  4. Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment\n  5. Cardiac surgery within 90 days prior to the point of enrollment\n* Severe aortic, mitral and\u002For pulmonic valve stenosis and\u002For regurgitation\n* Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid stenosis\n* Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days\n* Patient is oxygen-dependent or requires continuous home oxygen\n* Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days)\n* Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator\n* Patient is currently participating in another investigational biologic, drug, or device clinical study\n* Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship\n* Any patient considered to be vulnerable",{"count":73,"type":21},1270,[51],"To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team",[77,78,79],"Tricuspid Regurgitation","Tricuspid Valve Insufficiency","Tricuspid Valve Disease","2026-05-27",{"date":82,"type":31},"2026-05-29",{"date":84,"type":31},"2019-12-11",{"date":86,"type":21},"2031-12-31",{"name":37,"class":38},79,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":63},"100639899","konect-resilia-aortic-valved-conduit-avc-real-world-study-assessing-safety-and-performance-100639899","NCT07619872","KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance","KONECTION","Inclusion Criteria:\n\n1. 18 years or older at the time of informed consent\n2. Have a diseased native or prosthetic aortic valve and a damaged or diseased ascending aorta that requires aortic valved conduit replacement surgery with the KONECT RESILIA AVC\n3. Provide written informed consent\n4. Willing to follow protocol requirements\n\nExclusion Criteria:\n\n1. Active endocarditis or endocarditis within 3 months prior to the study index procedure\n2. Emergency procedure\n3. Stage 4 renal disease (estimated glomerular filtration rate \\[eGFR\\] \\\u003C30 excluded) or requiring dialysis\n4. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease in the opinion of the study investigator\n5. High predicted risk of mortality prior to the procedure: Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) ≥8%",{"count":97,"type":21},250,"KONECTION is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in up to 250 participants who will receive the KONECT RESILIA aortic valved conduit, Model 11060A.",[26],[101],"Bentall","NOT_YET_RECRUITING","2026-05-26",{"date":105,"type":31},"2026-06-02",{"date":107,"type":21},"2026-06-30",{"date":109,"type":21},"2039-06-30",{"name":37,"class":38},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":49,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100433119","tvmr-with-the-innovalve-system-trial---early-feasibility-study-100433119","NCT04919980","TVMR With the INNOVALVE System Trial - Early Feasibility Study","TWIST-EFS","Inclusion Criteria:\n\n* Clinically significant, symptomatic mitral regurgitation\n* High risk for open-heart surgery\n* Meets anatomical criteria\n\nExclusion Criteria:\n\n* Unsuitable anatomy\n* Patient is inoperable\n* EF\\\u003C25%",{"count":119,"type":21},65,[51],"Study to evaluate the safety and performance of the INNOVALVE system",[123],"Mitral Valve Regurgitation (Degenerative or Functional)",{"date":125,"type":31},"2026-05-28",{"date":127,"type":31},"2022-09-01",{"date":129,"type":21},"2031-07-01",{"name":37,"class":38},20,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":49,"phases":141,"briefSummary":142,"conditions":143,"keywords":148,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},"100266200","compassion-s3---evaluation-of-the-sapien-3-transcatheter-heart-valve-in-patients-with-pulmonary-valve-dysfunction-100266200","NCT02744677","COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction","COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV","Inclusion Criteria:\n\n1. Weight ≥ 20 kg (44 lbs.)\n2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use\n3. Subject presents with at least moderate PR and\u002For mean RVOT gradient ≥ 35 mmHg.\n4. The subject\u002Fsubject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)\n2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days\n3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder\n4. Inappropriate anatomy for femoral introduction and delivery of the study valve\n5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty\n6. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)\n7. Interventional\u002Fsurgical procedures within 30 days prior to the TPVI procedure.\n8. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.\n9. History of or current intravenous drug use\n10. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year\n11. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and\u002For antithrombotic medications\n12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated\n13. Participating in another investigational drug or device study that has not reached its primary endpoint.\n14. Female who is lactating or pregnant",{"count":140,"type":21},108,[51],"This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3\u002FSAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.",[144,145,146,147],"Complex Congenital Heart Defect","Dysfunctional RVOT Conduit","Pulmonary Valve Insufficiency","Pulmonary Valve Degeneration",[149,150,151,152,153,154,155,156,157,158,159],"Tetralogy of Fallot","Aortic Valve Defect\u002FDisease Resulting in Ross Procedure","Pulmonary Atresia","Pulmonary Stenosis","Truncus Arteriosus","Transposition of the Great Arteries","Transcatheter pulmonary valve implantation","Transcatheter pulmonary valve replacement","TPV","TPVR","TPVI","2026-03-04",{"date":162,"type":31},"2026-03-06",{"date":164,"type":31},"2016-07-05",{"date":166,"type":21},"2031-06",{"name":37,"class":38},25,{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":49,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},"100374271","the-encircle-trial-100374271","NCT04153292","The ENCIRCLE Trial","SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access","ENCIRCLE","Inclusion Criteria:\n\n1. 18 years of age or older\n2. MR ≥ 3+\n3. NYHA functional class ≥ II\n4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.\n5. Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment.\n6. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Mitral\u002Fcardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve\n2. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve\n3. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation\n4. Left ventricular ejection fraction \\\u003C25%\n5. Severe right ventricular dysfunction\n6. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months\n7. History of heart transplant\n8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation\n9. Active bacterial endocarditis within 180 days of the procedure\n10. Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure\n11. Myocardial infarction within 30 days of the procedure\n12. Clinically significant untreated coronary artery disease requiring revascularization\n13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure\n14. Stroke or transient ischemic attack within 90 days of the procedure\n15. Irreversible, severe pulmonary hypertension\n16. Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use\n17. Renal insufficiency or receiving renal replacement therapy\n18. Liver disease\n19. Planned surgery within the next 12 months\n20. Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure\n21. Active infection requiring current antibiotic therapy\n22. Active SARS-CoV-2 infection (Coronavirus-19 \\[COVID-19\\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments\n23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states\n24. Refusal of blood products\n25. Female who is pregnant or lactating\n26. Estimated life expectancy \\\u003C12 months due to non-cardiac conditions\n27. Participating in another investigational drug or device study that has not reached its primary endpoint\n28. Subject considered to be part of a vulnerable population",{"count":178,"type":21},900,[51],"This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.\n\nFollowing completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.",[182,183],"Mitral Regurgitation","Mitral Valve Insufficiency","2026-02-23",{"date":186,"type":31},"2026-02-25",{"date":188,"type":31},"2020-11-12",{"date":190,"type":21},"2031-02-28",{"name":37,"class":38},68,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},"100597538","mitris-china-post-market-clinical-follow-up-pmcf-study-100597538","NCT07059793","MITRIS China Post Market Clinical Follow-up (PMCF) Study","Post-Market Clinical Follow-up Study of Edwards Lifesciences MITRIS RESILIA Mitral Valve in Chinese Population","MITRIS China","Inclusion Criteria:\n\n1. 18 years or older at the time of informed consent\n2. Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery\n3. Provide signed written informed consent prior to the study participation\n4. Willingness to follow protocol requirements\n\nExclusion Criteria:\n\n1. Active endocarditis 3 months prior to the procedure\n2. Stage 4 renal disease or requiring dialysis (eGFR \\\u003C 30 is excluded)\n3. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease\n4. High predicted risk of mortality prior to procedure - STS Predicted Risk of Mortality (PROM) \\> 8 or Surgeon estimated risk of mortality of \\> 8 (STS PROM risk calculation score must be used for patients undergoing Isolated Mitral Valve Replacement (MVR) or MVR+ Coronary Artery Bypass Grafting (CABG). Surgeon estimated risk of mortality may only be used for patients who do not qualify for evaluation against those surgical models.)\n5. Participating in a drug or device study that has not reached its primary endpoint. Note: Participation in national registries is not an exclusion.",{"count":97,"type":21},"Collect clinical outcomes on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.",[204],"Mitral Valve Replacement","2025-12-23",{"date":207,"type":31},"2025-12-30",{"date":209,"type":31},"2025-07-08",{"date":211,"type":21},"2038-12",{"name":37,"class":38},13,{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":49,"phases":223,"briefSummary":224,"conditions":225,"keywords":228,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100528933","alliance-mitral-safety-and-effectiveness-of-sapien-x4-transcatheter-heart-valve---mitral-100528933","NCT06167213","ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral","Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve - Mitral","Inclusion Criteria:\n\n1. Failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring demonstrating ≥ moderate stenosis and\u002For ≥ moderate insufficiency\n2. Bioprosthetic surgical valve or native mitral annulus size suitable for SAPIEN X4 THV\n3. NYHA functional class ≥ II\n4. Heart Team agrees the subject is at high or greater surgical risk\n5. The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system\n2. Interatrial septum or left atrium not suitable for transcatheter transseptal access\n3. Failing valve has mild or greater paravalvular regurgitation\n4. Failing valve is unstable, rocking, or not structurally intact\n5. Annuloplasty ring dehiscence\n6. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \\> 10 mmHg at the end of the index procedure for implantation of the original valve\n7. Annuloplasty ring type not favorable for THV implantation\n8. Increased risk of THV embolization\n9. Anatomical characteristics that would increase risk of left ventricular outflow tract (LVOT) obstruction\n10. Surgical or transcatheter aortic valve extending into LVOT that may impinge on the mitral implant\n11. Severe right ventricle (RV) dysfunction\n12. Severe regurgitation or stenosis of any other valve\n13. Need for aortic, tricuspid, or pulmonic valve intervention within the next 12 months\n14. Left ventricular ejection fraction \\\u003C 20%\n15. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation\n16. Myocardial infarction within 30 days prior to the study procedure\n17. Hypertrophic cardiomyopathy with subvalvular obstruction\n18. Subjects with planned concomitant ablation for atrial fibrillation\n19. Clinically significant coronary artery disease requiring revascularization\n20. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.\n21. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure\n22. Endocarditis within 180 days prior to the study procedure\n23. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure\n24. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure\n25. Renal insufficiency and\u002For renal replacement therapy\n26. Leukopenia, anemia, thrombocytopenia\n27. Inability to tolerate or condition precluding treatment with antithrombotic therapy\n28. Hypercoagulable state or other condition that increases risk of thrombosis\n29. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication\n30. Subject refuses blood products\n31. Body mass index \\> 50 kg\u002Fm2\n32. Estimated life expectancy \\\u003C 24 months\n33. Female who is pregnant or lactating\n34. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments\n35. Participating in another investigational drug or device study that has not reached its primary endpoint\n36. Subject considered to be part of a vulnerable population",{"count":222,"type":21},125,[51],"This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring.",[182,226,227],"Mitral Valve Disease","Mitral Stenosis",[229,230,231],"SAPIEN X4","Valve-in-Valve","Valve-in-Ring","2025-12-18",{"date":234,"type":31},"2025-12-22",{"date":236,"type":21},"2027-01",{"date":238,"type":21},"2038-03",{"name":37,"class":38},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":49,"phases":249,"briefSummary":250,"conditions":251,"keywords":254,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":264},"100452551","alliance-aviv-safety-and-effectiveness-of-the-sapien-x4-transcatheter-heart-valve-in-failing-aortic-bioprosthetic-valves-100452551","NCT05172973","ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves","Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves","Inclusion Criteria:\n\n1. Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and\u002For ≥ moderate insufficiency\n2. Bioprosthetic valve size suitable for SAPIEN X4 THV\n3. NYHA functional class ≥ II\n4. Heart Team agrees the subject is at high or greater surgical risk\n5. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system\n2. Failing valve has moderate or severe paravalvular regurgitation\n3. Failing valve is unstable, rocking, or not structurally intact\n4. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \\> 20 mmHg at the end of the index procedure for implantation of the original valve\n5. Increased risk of THV embolization\n6. Surgical or transcatheter valve in the mitral position\n7. Severe mitral regurgitation (\\> 3+) or ≥ moderate mitral stenosis\n8. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months\n9. Left ventricular ejection fraction \\\u003C 20%\n10. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation\n11. Increased risk of coronary artery obstruction after THV implantation\n12. Myocardial infarction within 30 days prior to the study procedure\n13. Hypertrophic cardiomyopathy with subvalvular obstruction\n14. Subjects with planned concomitant ablation for atrial fibrillation\n15. Clinically significant coronary artery disease requiring revascularization\n16. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.\n17. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure\n18. Endocarditis within 180 days prior to the study procedure\n19. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure\n20. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure\n21. Renal insufficiency and\u002For renal replacement therapy\n22. Leukopenia, anemia, thrombocytopenia\n23. Inability to tolerate or condition precluding treatment with antithrombotic therapy\n24. Hypercoagulable state or other condition that increases risk of thrombosis\n25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication\n26. Subject refuses blood products\n27. Body mass index \\> 50 kg\u002Fm2\n28. Estimated life expectancy \\\u003C 24 months\n29. Female who is pregnant or lactating\n30. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments\n31. Participating in another investigational drug or device study that has not reached its primary endpoint\n32. Subject considered to be part of a vulnerable population",{"count":248,"type":21},200,[51],"The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.",[252,253],"Aortic Valve Insufficiency","Aortic Valve Stenosis",[255,256,229,257],"Transcatheter aortic valve replacement (TAVR)","Transcatheter aortic valve implantation (TAVI)","Valve-in-valve",{"date":234,"type":31},{"date":260,"type":31},"2023-11-22",{"date":262,"type":21},"2036-02",{"name":37,"class":38},35,{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":17,"minAge":273,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":49,"phases":276,"briefSummary":277,"conditions":278,"keywords":280,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":295},"100430806","progress-management-of-moderate-aortic-stenosis-by-clinical-surveillance-or-tavr-100430806","NCT04889872","PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR","The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement","PROGRESS","Key Inclusion Criteria:\n\n1. 65 years of age or older at time of randomization\n2. Moderate aortic stenosis\n3. Subject has symptoms or evidence of cardiac damage\u002Fdysfunction\n4. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.\n\nKey Exclusion Criteria:\n\n1. Native aortic annulus size unsuitable for the THV\n2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system\n3. Aortic valve is unicuspid or non-calcified\n4. Bicuspid aortic valve with an aneurysmal ascending aorta \\> 4.5 cm or severe raphe\u002Fleaflet calcification\n5. Pre-existing mechanical or bioprosthetic aortic valve\n6. Severe aortic regurgitation\n7. Prior balloon aortic valvuloplasty to treat severe AS\n8. LVEF \\\u003C 20%\n9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR\n10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation\n11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR","65 Years",{"count":275,"type":21},2250,[51],"This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 \u002F SAPIEN 3 Ultra \u002F SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.\n\nFollowing completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.",[279,253],"Aortic Stenosis, Calcific",[255,281,282,283,284,285,286],"SAPIEN 3","SAPIEN 3 Ultra","SAPIEN 3 Ultra RESILIA","Moderate aortic stenosis","Aortic stenosis","Transcatheter heart valve","2025-12-12",{"date":289,"type":31},"2025-12-17",{"date":291,"type":31},"2021-10-12",{"date":293,"type":21},"2037-06",{"name":37,"class":38},80,{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":314,"locationsCount":63},"100604346","hemosphere-alta-study-100604346","NCT07148323","HemoSphere Alta Study","HemoSphere Alta Clinical Development Study","Inclusion Criteria:\n\n1. Signed informed consent\n2. Age ≥ 18 years\n3. Planned monitoring with a pulmonary artery catheter\n4. Patient scheduled to undergo cardiac or liver transplant surgery lasting \\> 2 hours\n5. Additional criteria for Sub-Cohort A (RVF)\n\n   1. Possible Right Ventricular Dysfunction\u002FFailure based on pre-operative assessment of previous Transthoracic Echocardiogram (TTE)\n   2. Planned Transesophageal Echocardiogram (TEE) assessment during the operative procedure\n6. Additional criteria for Sub-Cohort B (CAI)\n\n   1. Age ≥ 45 years\n   2. Planned cardiac surgery with Cardiopulmonary Bypass (CPB)\n   3. Ability to place ForeSight IQ and Acumen IQ sensors during the operative monitoring period\n   4. High risk for cerebral vascular disease, defined as: a history of hypertension, pulse pressure \\> 60 mmHg, diabetes, stroke, transient ischemic attack, carotid bruit, tobacco smoking, or peripheral vascular disease\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. Pregnancy as confirmed per EMR\n3. Patients deemed not suitable for the study at the discretion of the Investigator\n4. Participation in another study that clinically interferes with the current study\n5. Additional exclusion criteria for Sub-Cohort A\n\n   1. Presence of left bundle branch block\n   2. Presence of current\u002Frecurrent sepsis\n   3. Presence of hypercoagulability, as identified in the patient's past medical history and preoperative evaluation\n   4. Structural abnormality, including congenital heart defects, of the right ventricle\n6. Additional exclusion criteria for Sub-Cohort B a. Surgery for congenital heart defect",{"count":304,"type":21},100,"A prospective, non-randomized single arm study using the HemoSphere Alta Advanced Monitoring Platform and associated devices in adult subjects. Data collected from enrolled study subjects will be used for continual device development purposes.",[307],"Hemodynamic Instability","2025-11-06",{"date":310,"type":31},"2025-11-10",{"date":312,"type":31},"2025-10-14",{"date":35,"type":21},{"name":37,"class":38},{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":17,"minAge":322,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":49,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":63},"100553950","personal-bp---cai-study-100553950","NCT06492746","Personal BP - CAI Study","Assessing for Personalized Blood Pressure Targets During Cardiopulmonary Bypass With the Proprietary Cerebral Adaptive Index: A Pilot Investigation","Inclusion Criteria:\n\n1. Signed informed consent\n2. Age ≥ 45 years\n3. Planned cardiac surgery with Cardiopulmonary Bypass (CPB)\n4. Planned monitoring with ForeSight sensor and HemoSphere monitor\n5. Planned arterial catheterization for blood pressure monitoring\n6. High risk for cerebral vascular disease, defined as: a history of hypertension, pulse pressure \\> 60 mmHg, diabetes, stroke, transient ischemic attack, carotid bruit, tobacco smoking, or peripheral vascular disease\n\nExclusion Criteria:\n\n1. Non-English speaking\n2. Confirmed to be pregnant\n3. Surgery for congenital heart defect\n4. Non-availability of HemoSphere with laptop CAI interface","45 Years",{"count":324,"type":21},120,[51],"A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets",[54],"2025-07-09",{"date":330,"type":31},"2025-07-14",{"date":332,"type":31},"2024-06-03",{"date":334,"type":21},"2025-12",{"name":37,"class":38},{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":357},"100395513","miclasp-post-market-clinical-follow-up-pmcf-study-100395513","NCT04430075","MiCLASP Post Market Clinical Follow-Up (PMCF) Study","Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)","MiCLASP","Inclusion Criteria:\n\n1. Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement\n2. Patient is willing and able to attend all follow-up visits and to perform all tests\n3. Provision of written informed consent\n\nExclusion Criteria:\n\n1. Patients are not eligible per the current Instructions for Use\n2. Non-elective or emergency TEER procedure for mitral regurgitation\n3. Patients in ICU prior to the index procedure",{"count":345,"type":21},1000,"This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.",[182,348],"Mitral Insufficiency","2025-06-25",{"date":351,"type":31},"2025-06-26",{"date":353,"type":31},"2019-08-23",{"date":355,"type":21},"2031-03-31",{"name":37,"class":38},37,{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":17,"minAge":273,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":368,"conditions":369,"keywords":370,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":63},"100580144","ttvr-strong-under-coverage-with-evidence-development-ced-study-100580144","NCT06833476","TTVR STRONG Under Coverage With Evidence Development (CED) Study","Transcatheter Tricuspid Valve Replacement (TTVR) in Patients With Severe TR ONgoing Evidence Generation (STRONG) Under Coverage With Evidence Development (CED)","STRONG","Inclusion Criteria:\n\nMedicare eligible patients who have received an EVOQUE device or are EVOQUE eligible and have at least severe Tricuspid Regurgitation\n\nExclusion Criteria:\n\nCommercially insured patients who have received an EVOQUE device or are EVOQUE eligible or Medicare eligible patients with less than severe Tricuspid Regurgitation",{"count":367,"type":21},2044,"This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement procedure using the EVOQUE system.",[77],[371,372,373,374],"EVOQUE","Coverage with Evidence Development","CED","TVT Registry","2025-03-27",{"date":377,"type":31},"2025-03-28",{"date":379,"type":31},"2025-03-19",{"date":381,"type":21},"2032-12-31",{"name":37,"class":38},{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":404},"100559858","real-world-european-investigation-of-safety-and-clinical-efficacy-of-the-evoque-system-triscend-iii-eu-100559858","NCT06569602","Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)","Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device","Inclusion Criteria:\n\n1. The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement with the EVOQUE system per the current instructions for use.\n2. Patient agrees to attend follow-up assessments.\n3. Patients provided written informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s).\n2. Any patient considered to be part of a vulnerable population.",{"count":20,"type":21},"This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.",[393,394,395],"Tricuspid Valve Regurgitation","Heart Valve Diseases","Cardiovascular Diseases","2024-10-29",{"date":398,"type":31},"2024-10-31",{"date":400,"type":31},"2024-10-01",{"date":402,"type":21},"2033-09-30",{"name":37,"class":38},2,{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":49,"phases":413,"briefSummary":414,"conditions":415,"keywords":418,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":436},"100286027","partner-3-trial---aortic-valve-in-valve-100286027","NCT03003299","PARTNER 3 Trial - Aortic Valve-in-Valve","A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3\u002FSAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve","Inclusion Criteria:\n\n1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and\u002For ≥ moderate insufficiency.\n2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.\n3. NYHA Functional Class ≥ II.\n4. Heart Team agrees the patient is low to intermediate risk.\n5. Heart Team agrees valve implantation will likely benefit the patient.\n6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)\n2. Severe regurgitation (\\> 3+) or stenosis of any other valve\n3. Failing valve has moderate or severe paravalvular regurgitation\n4. Failing valve is unstable, rocking, or not structurally intact\n5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.\n6. Increased risk of embolization of THV\n7. Known bioprosthetic valve with residual mean gradient \\> 20 mmHg at the end of the index procedure for implantation of the original valve\n8. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)\n9. Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)\n10. Anatomical characteristics that would preclude safe access to the apex (Transapical)\n11. Evidence of an acute myocardial infarction ≤ 30 days before enrollment\n12. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.\n13. Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation\n14. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states\n15. Untreated clinically significant coronary artery disease requiring revascularization\n16. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment\n17. Emergency interventional\u002Fsurgical procedures within 30 days prior to the procedure\n18. Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure\n19. Hypertrophic cardiomyopathy with obstruction\n20. LVEF \\\u003C 30%\n21. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation\n22. Inability to tolerate or condition precluding treatment with antithrombotic\u002Fanticoagulation therapy during or after the valve implant procedure\n23. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication\n24. Stroke or transient ischemic attack within 90 days of enrollment\n25. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment\n26. Renal insufficiency and\u002For renal replacement therapy at the time of screening\n27. Active bacterial endocarditis within 180 days of the procedure\n28. Patient refuses blood products\n29. Estimated life expectancy \\\u003C 24 months\n30. Positive urine or serum pregnancy test in female subjects of childbearing potential\n31. Currently participating in an investigational drug or another device study",{"count":222,"type":21},[51],"This study will assess the safety and effectiveness of the SAPIEN 3\u002FSAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.",[416,417],"Aortic Stenosis","Aortic Stenosis, Severe",[281,419,420,421,422,423,424,425,426,427,282],"PARTNER 3","cardiovascular disease","heart disease","aortic stenosis","SAVR","TAVR","failing surgical valve","failing bioprosthetic valve","failing valve","2024-05-08",{"date":430,"type":31},"2024-05-10",{"date":432,"type":31},"2017-01-05",{"date":434,"type":21},"2038-04",{"name":37,"class":38},51,""]