[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"P+F Products + Features USA Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100551347","pivotal-trial-to-evaluate-the-safety-and-effectiveness-of-the-pf-tricvalve-transcatheter-bicaval-valve-system-100551347",false,"NCT06458907","Pivotal Trial to Evaluate the Safety and Effectiveness of the P&F TricValve® Transcatheter Bicaval Valve System","A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.","TRICAV-II","Eligibility Criteria for Randomized Cohort:\n\nInclusion Criteria:\n\n1. Age between 18 years and 85 years old, at the time of signing the informed consent.\n2. Severe tricuspid regurgitation (TR) and Caval Reflux (CR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab. TVARC criteria will be used for the definition of TR severity.\n3. NYHA Class II-III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.\n4. Adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team at the time of TR assessment for eligibility (TTE). OMT includes stable oral diuretic medications.\n5. High risk for open surgery and is appropriate for transcatheter tricuspid therapies according to the local heart team.\n6. Patient is unsuitable for approved transcatheter therapies and is eligible for the TricValve procedure, based on review of screening\u002Fbaseline data and imaging core lab measurements by Central Screening Committee.\n7. For females of childbearing potential, negative pregnancy test.\n8. Capable and willing to provide signed informed consent\n\nExclusion Criteria:\n\nCONCOMITANT PROCEDURES\n\n1. Patient had a recent MI, stroke, or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention or other major cardiovascular surgery within 90 days prior to TricValve implantation.\n2. Patient requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis, severe mitral regurgitation), coronary artery bypass or PCI or pulmonary valve correction.\n\n   CARDIOVASCULAR CONDITIONS\n3. LVEF ≤ 30% on echocardiography.\n4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.\n5. Severe right ventricular dysfunction.\n6. Cardiac amyloidosis.\n7. Pulmonary artery systolic pressure (PASP) \\>65 mmHg assessed with Echo Doppler and \u002For right heart catheterization.\n8. Lower extremity venous thrombosis and\u002For the presence of an IVC filter at the time of or 6 months prior to the TricValve procedure.\n9. Hemodynamically significant pericardial effusion.\n10. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.\n11. Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC\u002F AHA\u002F ESC\u002F EACTS Stage D heart failure).\n12. Presence of significant congenital or acquired heart disease such as RV dysplasia, arrhythmogenic RV or other conditions that could interfere with the TricValve procedure.\n\n    ALLERGIES \u002F INTOLERANCE\n13. Any known allergy or hypersensitivity to nitinol, bovine tissue, or contrast media that cannot be adequately treated with pre-medication.\n14. Unable to tolerate anticoagulation\u002Fantiplatelet therapy\n\n    COMORBIDITIES\n15. Any known life-threatening condition with an estimated life span of less than 12 months.\n16. Platelet count \\\u003C 75,000\u002Fmm3\n17. Child-Pugh Severity Class C (10-15 points).\n18. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 30 mL\u002Fmin\u002F1.73 m2 or requiring chronic renal replacement therapy at the time of enrollment.\n19. Endocarditis or active\u002Fongoing infection requiring antibiotics.\n20. Unable to walk at least 100 meters in a 6-minute walk test.\n21. Known bleeding or clotting disorders or patient refuses blood transfusion.\n22. Active gastrointestinal (GI) bleeding within 3 months of TricValve procedure.\n23. Prior Malignancy: this study excludes participants at material risk of near-term cancer-related morbidity\u002Fmortality that could confound 12-month outcomes. This study allows the inclusion of fully treated, remote malignancies with documented No Evidence of Disease (NED)\" criteria\n\n    a. History of any malignancy within 5 years prior to randomization or any active malignancy, except: i. Adequately treated non-melanoma skin cancer (basal or squamous cell) with no evidence of disease, or ii. Carcinoma in situ (e.g., cervical, breast DCIS) treated with curative intent and no evidence of disease.\n\n    b. Participants with a prior malignancy diagnosed \\>5 years before randomization are eligible if they meet all of the \"No Evidence of Disease (NED)\" criteria as specified below: i. No signs\u002Fsymptoms of cancer on history and physical exam per standard of care; ii. No radiologic evidence of disease on surveillance imaging if such imaging is routinely indicated for that tumor type (not protocol-mandated); iii. Tumor markers (if applicable for that cancer) not suggestive of recurrence (e.g., stable\u002Fundetectable within site's lab reference and oncologist's judgment); iv. No active anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy, radiotherapy) and none planned; v. Treating oncologist's attestation (or primary physician if oncology follow-up is complete) that the participant is disease-free and appropriate for participation.\n\n    GENERAL EXCLUSIONS\n24. Use or participation in other investigational device or drug study in which the patient has not reached a primary endpoint to treat cardiovascular conditions related to the outcomes of the current study.\n25. Any other condition that would preclude the ability to meet study requirements in the opinion of the investigator.\n26. Psychiatric\u002Fbehavioral issues or other medical or social conditions that preclude valid consent and follow-up\n27. Pregnant or breastfeeding subjects and those who plan pregnancy during the clinical investigation follow-up period.\n\nEligibility Criteria for Single Arm Cohort:\n\nInclusion Criteria:\n\n1. Age \\> 85 years.\n2. NYHA Class III-IV, on intravenous inotropes, IABP or LVAD.\n3. LVEF ≤ 30% on echocardiography.\n4. Severe RV dysfunction.\n5. Severe pulmonary hypertension (PH), defined as Pulmonary artery systolic pressure (PASP) \\>65 mmHg assessed with Echo Doppler and \u002For mean Pulmonary Artery Pressure (mPAP \\>35) by right heart catheterization.\n6. Renal insufficiency: eGFR between 25 and 30 mL\u002Fmin\u002F 1.73 m² or on chronic renal replacement therapy.\n7. Patient unable to walk a minimum distance of 100 mt during 6 minute walk test.\n8. Prior malignancy not meeting the requirements applied for the Randomized Cohort, specified in Exclusion Criterion #23.\n9. Comorbidities precluding inclusion in the Randomized Cohort (exclusion criteria #15 to #24).","ALL","18 Years","85 Years",{"count":21,"type":22},780,"ESTIMATED","INTERVENTIONAL",[25],"NA","Pivotal trial to evaluate the safety and effectiveness of the P\\&F TricValve® Transcatheter Bicaval Valve System.",[28,29,30,31,32,33],"Tricuspid Valve Disease","Heart Valve Diseases","Cardiovascular Diseases","Heart Failure","Tricuspid Valve Regurgitation","Tricuspid Valve Insufficiency","NOT_YET_RECRUITING","2026-05-19",{"date":37,"type":38},"2026-05-22","ACTUAL",{"date":40,"type":22},"2026-04",{"date":42,"type":22},"2032-11",{"name":44,"class":45},"P+F Products + Features USA Inc.","INDUSTRY",35,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100526673","tricvalve-bicaval-valve-system-for-severe-tricuspid-regurgitation-tricav-i-100526673","NCT06137807","TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)","A Prospective, Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation - TRICAV-I Trial","TRICAV-I","Inclusion Criteria:\n\n1. Subject must be 18 years or older, at the time of signing the informed consent.\n2. Subjects has severe tricuspid regurgitation (TR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab.\n3. NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.\n4. Subject is adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team for at least 30 days prior to the index procedure, including a diuretic.\n5. The local Heart Team and IEC determine that the patient is eligible for the TricValve procedure.\n6. For females of childbearing potential, negative pregnancy test.\n7. Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n1. Subject had a recent MI, stroke or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention or other major cardiovascular surgery within 90 days prior to TricValve implantation.\n2. Subject requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis, severe mitral regurgitation), coronary artery bypass or PCI or pulmonary valve correction. Please note that if closure of an ASD, iatrogenic ASD or PFO is performed, TricValve implantation can be performed 30 days after the intervention. Additionally, TricValve implantation can be performed 30 days after any Electrophysiology procedure (pacemaker, ICD, etc.).\n3. LVEF ≤ 30% on echocardiography.\n4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.\n5. Tricuspid stenosis. (Per TVARC, echo criteria: TVA at least 1.5 cm2 or TVAi at least 0.9 cm2\u002Fm2 \\[at least 0.75 if BMI \\>30 kg\u002Fm2\\], DVI \\\u003C2.2, mean gradient \\\u003C5mm Hg); reduction of total tricuspid regurgitation to optimal (≤ mild \\[1+\\]) or acceptable (≤ moderate \\[2+\\]).\n6. Severe right ventricular dysfunction.\n7. Cardiac amyloidosis\n8. Pulmonary artery systolic pressure (PASP) \\>65 mmHg assessed with Echo Doppler and \u002For right heart catheterization.\n9. Lower extremity venous thrombosis and\u002For the presence of an IVC filter at the time of or 6 months prior to TricValve procedure.\n10. Hemodynamically significant pericardial effusion.\n11. Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC\u002F AHA\u002F ESC\u002F EACTS Stage D heart failure)\n12. Any known allergy or hypersensitivity to nitinol, bovine tissue or contrast media that cannot be adequately treated with pre-medication.\n13. Unable to tolerate anticoagulation\u002Fantiplatelet therapy\n14. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.\n15. Any known life-threatening condition with an estimated life span of at least 12 months.\n16. Platelet count \\\u003C 75,000\u002Fmm3\n17. Child-Pugh Severity Class C (10-15 points).\n18. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25 mL\u002Fmin\u002F1.73 m2 or requiring chronic renal replacement therapy at the time of enrollment.\n19. Endocarditis or active\u002Fongoing infection requiring antibiotics.\n20. Unable to walk at least 60 meters in a 6minute walk test.\n21. Known bleeding or clotting disorders or patient refuses blood transfusion.\n22. Active gastrointestinal (GI) bleeding within 3 months of randomization.\n23. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.\n24. Use or participation in other investigational device or drug study in which patient has not reached a primary endpoint to treat cardiovascular conditions related to the outcomes of the current study.\n25. Any other condition that would preclude ability to meet study requirements in the opinion of the investigator.\n26. Psychiatric\u002Fbehavioral issues or other medical or social conditions that preclude valid consent and follow-up\n27. Pregnant or breastfeeding subjects and those who plan pregnancy during the clinical investigation follow-up period.",{"count":56,"type":22},50,[25],"The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.",[60,28],"Tricuspid Regurgitation",[60,31],"RECRUITING","2025-06-04",{"date":65,"type":38},"2025-06-08",{"date":67,"type":38},"2024-07-23",{"date":69,"type":22},"2029-09",{"name":44,"class":45},36,""]