[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"P+F Products + Features GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,78],{"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":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100428649","pivotal-study-of-the-vienna-transcatheter-self-expandable-aortic-valve-se-system-100428649",false,"NCT04861805","Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System","A Two -Stage First in Human (FIH) Feasibility \u002F Pivotal Study of the Vienna Aortic Valve SE System","VIVA","Inclusion criteria:\n\n1. Male or Female\n2. Age ≥ 65 years at time of consent\n3. Women of non-childbearing potential\n4. Severe degenerative calcific native aortic valve stenosis with the following criteria assessed either by resting or dobutamine stress TTE:\n\n   1. Aortic valve area (AVA) \\\u003C 1.0 cm2 or AVA index ≤ 0.6 cm2\u002Fm2 and\n   2. Jet velocity \\> 4.0 m\u002Fs or mean gradient \\> 40 mmHg\n5. Symptomatic aortic stenosis (AS), defined as a history of at least one of the following:\n\n   1. Dyspnea that qualifies at NYHA class II or greater\n   2. Angina pectoris\n   3. Cardiac syncope\n6. Subject is considered at intermediate or high risk for surgical valve replacement based on at least one of the following:\n\n   1. EuroSCORE II ≥ 4% along with assessment of frailty, major organ system dysfunction, and procedure-specific impediments, in accordance with scientific guidelines\n   2. Agreement by the Heart Team that subject is at moderate to high operative risk of serious morbidity or mortality with surgical valve replacement.\n7. The local Heart Team deems the patient to be eligible for transfemoral TAVI.\n8. Perimeter-based aortic annulus diameter between ≥ 18 and ≤ 29 mm measured by computed tomography (CT) analyzed by a core lab.\n9. Adequate iliofemoral access with either:\n\n   1. At least one side with minimum vessel diameter ≥ 6.0 mm and acceptable level of vessel calcification and tortuosity for safe placement of the introducer sheath, as analyzed by a core lab, OR\n   2. At least one side with minimum vessel diameter ≥ 5.5 and no significant calcification or severe tortuosity for safe placement of the introducer sheath, as analyzed by a core lab.\n10. Patient (or legal representative) understands the study requirements and the treatment procedures and provides written informed consent.\n11. The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.\n\nExclusion Criteria:\n\nCardiovascular System:\n\n1. Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.\n2. Evidence of an acute myocardial infarction (MI) ≤ 30 days prior to screening or IMD implantation (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and\u002For troponin elevation).\n3. Patient has had a cerebrovascular stroke or TIA within the past 90 days implantation prior to screening or valve implantation.\n4. Patient has a hypertrophic obstructive cardiomyopathy.\n5. History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to screening or IMD implantation (except for pacemaker implantation which is allowed).\n6. Untreated clinically significant coronary artery disease requiring revascularization at the screening visit.\n7. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \\\u003C 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.\n8. Patient with cardiogenic shock manifested by low cardiac output and hemodynamic instability and vasopressor dependence, or mechanical hemodynamic support\n9. Patients with clinically significant conduction abnormalities (clinically significant sinus bradycardia, sinus block or pauses, clinically significant atrioventricular (AV)-block \\>I) at screening and at time of IMD implantation.\n10. Patient has severe peripheral vascular disease:\n\n    1. including aortic aneurysm defined as maximal luminal diameter \\> 5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick \\[\\> 5 mm\\], protruding or ulcerated atheroma in the aortic arch) or\n    2. symptomatic carotid or vertebral disease or successful treatment of carotid stenosis within 30 days prior to screening or IMD implantation.\n11. Patient with iliofemoral vessel characteristics that would preclude safe passage of the introducer (both sides), as analyzed by a core lab:\n\n    1. severe calcification,\n    2. severe tortuosity (\\> two 90-degree bends),\n    3. diameter \\\u003C 6 mm, in patients with acceptable levels of calcification and acceptable levels of tortuosity\n    4. diameter \\\u003C 5.5, in patients with no calcification and no significant tortuosity, OR\n    5. subject has had an aorto-femoral bypass\n12. Patient with active bacterial endocarditis within 6 months prior to screening or IMD implantation.\n13. Patient has (echocardiographic\u002F CT and\u002For MRI) evidence of intra-cardiac mass, thrombus or vegetation.\n14. Patient has a pre-existing prosthetic heart valve in any position (Note: mitral ring is not an exclusion).\n15. Patient has severe mitral regurgitation, severe aortic regurgitation or severe tricuspid regurgitation, moderate or severe mitral stenosis.\n16. Patient has a need for emergency surgery for any reason at time of screening or IMD implantation.\n\n    General:\n17. Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. patient with contraindication to oral antiplatelet therapy)\n18. Patient with renal insufficiency (eGFR \\\u003C 30 ml\u002Fmin per the Cockcroft-Gault formula) and\u002F or renal replacement therapy and\u002F or has serum creatinine level \\> 3.0 mg\u002FdL or 265 µmol\u002FL replacement therapy at the time of screening\n19. Patient with significant pulmonary disease (FEV1 \\\u003C 30%) or currently on home oxygen\n20. Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure ≥ 60 mmHg)\n21. Patients with evidence of an active systemic infection or sepsis.\n22. Patient has a known hypersensitivity or contraindication to contrast media, bovine tissue, nitinol (titanium or nickel), contraindication to oral antiplatelet therapy (aspirin, ticlopidine or clopidogrel) or heparin.\n23. Patient has a haemoglobin \\\u003C 9 g\u002FdL, platelet count \\\u003C 50,000 cells\u002Fmm3 or \\> 700.000 cells\u002Fmm3, or white blood cell count \\\u003C 1.000 cells\u002Fmm3, history of bleeding diathesis or coagulopathy\n24. Patient has peptic ulcer disease or history of gastrointestinal bleeding within the 3 months prior to screening or IMD implantation.\n25. Patient refuses blood transfusions.\n26. Patient has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrolment (i.e. the time of informed consent).\n27. Patient is pregnant or breast feeding.\n28. Severe dementia (resulting in either inability to provide informed consent for the study\u002Fprocedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).\n29. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the patient from appropriate consent or adherence to the protocol required follow-up exams.\n30. Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint (excluding observational studies).","ALL","65 Years",{"count":20,"type":21},267,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, single arm, multicenter study in an cohort of up to 267 patients (up to 100 Roll-ins and 167 patients implanted per protocol) symptomatic patients with severe aortic stenosis who will be followed up for up to 5 years.",[27],"Symptomatic Aortic Stenosis",[29,30,31,32,33],"heart disease","aortic valve","SSAS","symptomatic severe aortic stenosis","heart valve","RECRUITING","2025-06-25",{"date":37,"type":38},"2025-06-29","ACTUAL",{"date":40,"type":38},"2023-07-03",{"date":42,"type":21},"2030-10",{"name":44,"class":45},"P+F Products + Features GmbH","INDUSTRY",31,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":67,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100448084","retrospective-prospective-multicentric-clinical-follow-up-of-patients-after-being-treated-with-tricvalve-100448084","NCT05114850","Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®","TRICUS REGISTRY - Retrospective Prospective Multicentric Clinical Follow up of Patients With Severe Tricuspid Regurgitation After Being Treated With the TricValve® Transcatheter Bicaval Valves System.","Inclusion Criteria:\n\n* Successful treatment with TricValve Transcatheter Bicaval Valves System\n* Patient\u002Fpatient's authorized legal guardian gives his consent to participate in the study and signed the corresponding inform consent\n\nExclusion Criteria:\n\n* no exclusion criterion","18 Years",{"count":56,"type":21},450,"5 Years","OBSERVATIONAL","Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.",[61,62,63,64,65,66],"Tricuspid Regurgitation","Tricuspid Valve Insufficiency","Tricuspid Insufficiency","Heart Failure","Heart Diseases","Heart Valve Diseases",[68],"Cardiovascular disease","2024-04-02",{"date":71,"type":38},"2024-04-03",{"date":73,"type":38},"2022-04-20",{"date":75,"type":21},"2028-12",{"name":44,"class":45},28,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100506253","munich-transcatheter-mitral-valve-safety-and-effectiveness-100506253","NCT05871983","Munich Transcatheter Mitral Valve Safety and Effectiveness","Clinical Evaluation of Safety and Effectiveness of the Munich Transcatheter Mitral Valve Replacement (TMVR) System","MUSE","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Moderate or severe mitral regurgitation (\\> 3+)\n\n   1. For Degenerative MR: EROA ≥ 40 mm2 or regurgitant volume ≥ 60ml\n   2. For Secondary MR: EROA \\> 30 mm2 or regurgitant volume \\> 45ml (i.e., MR moderate or severe by ASE criteria)\n3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV\n4. Subject is under guideline directed medical therapy for at least one month\n5. Subject is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty and disability\n6. Subject meets the anatomical criteria for Munich TMVR System\n7. Patient is willing to participate in the study and provides signed informed consent.\n\nExclusion Criteria:\n\nGeneral Conditions\n\n1. Subject who is currently participating in an investigational study, other than this study\n2. Subjects allergic to bovine tissue\n3. Subjects with uncontrolled hypotension\n4. Hemodynamic instability\n5. Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated and has an allergy to Nitinol alloys\n6. Intolerance to antiplatelet, anticoagulant or thrombolytic medications\n7. Bleeding diathesis or hypercoagulable state\n8. Active peptic ulcer or active gastrointestinal bleeding\n9. Pulmonary artery systolic pressure \\>70 mmHg\n10. Renal insufficiency\n11. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.\n12. Subject with hepatic insufficiency\n13. Subject has a co-morbid illness that may result in a life expectancy of less than one year\n14. Active infection that requires antibiotic therapy\n15. Subject is pregnant, breastfeeding or intend to become pregnant within one year, and female subjects in childbearing age NOT using a highly effective method of contraception with a failure rate of less than 1% per year.\n\n    Comorbidities\n16. Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability\n17. Acute myocardial infarction within the previous 30 day\n18. Any prior heart valve surgery or transcatheter mitral intervention\n19. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days\n20. Rheumatic heart disease or endocarditis within the previous 3 months\n21. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis\n22. Severe organic lesion with retracted chordae or congenital malformation and lack of valvular tissue\n23. Any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.\n24. Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)\n25. Untreated clinically significant coronary artery disease requiring revascularization\n26. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation\n27. Aortic or pulmonic valve disease requiring surgery\n28. CRT\u002FICD implant within 30 days\n29. NYHA class IVb\n30. UNOS stadium 1 heart transplantation or previous orthotopic heart transplantation\n\n    Anatomical and Functional\n31. Left Ventricular Ejection Fraction (LVEF) \\\u003C30%\n32. LV end diastolic diameter \\> 70mm\n33. Significant abnormalities of the sub-valvular apparatus.\n34. Severe mitral annular or leaflets calcification\n35. Left atrial or LV thrombus or vegetation\n36. Severe right ventricular dysfunction\n37. Severe tricuspid or aortic valve disease",true,{"count":88,"type":21},60,[24],"The Munich Trascatheter Mitral Valve System is intended for beating heart, mitral valve replacement in patients with a diseased, damaged, or malfunctioning mitral valve. Access is provided through the Femoral Vein and transseptal approach by means of a 27Fr catheter.\n\nThe bioprosthetic valve consists of a self-expanding, tri-leaflet, dry bovine-pericardial valve. The dry tissue allows the valve to be conveniently pre-loaded. The valve is available in three sizes and has been designed to reduce the complexity of implantation in comparison to other TMVR systems.",[92,93],"Mitral Regurgitation","Mitral Valve Disease",[95,96],"mitral regurgitation","heart failure","NOT_YET_RECRUITING","2023-07-07",{"date":100,"type":38},"2023-07-11",{"date":102,"type":21},"2023-07-30",{"date":104,"type":21},"2029-12-30",{"name":44,"class":45},10,""]