Cardiovalve
(TS) | Recruiting (30) NCT03339115 | Mortality, MACE, hospitalization, and device or procedural serious adverse events (15 December 2020) | Age ≥ 18 years; NYHA II, III or amb. IV; MR 3-4 +; GDMT and/or CRT; high surgical risk; TEE feasible; anatomical eligibility; suitable for femoral access procedure and TS catheterization | Stroke/TIA (3 months) or Modified Rankin Scale ≥ 4 disability; AMI (30 days); heart valve surgery or TC MV intervention; percutaneous CV intervention, CV surgery, or carotid surgery (30 days); rheumatic heart disease or endocarditis (3 months); hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, or any HF cause other than dilated cardiomyopathy; inferior vena cava filter or atrial septal device; clinically significant CAD requiring revascularization; tricuspid valve disease requiring surgery or severe tricuspid regurgitation; aortic or pulmonic valve disease requiring surgery; CRT/ICD (30 days); anatomical exclusion criteria; EF < 30%; LVEDD > 70 mm; severe MV annular or leaflets calcification; left atrial or LV thrombus or vegetation; severe RV dysfunction; severe tricuspid or aortic valve disease; hemodynamic instability; contrast agent hypersensitivity; allergy to nitinol alloys (nickel and titanium), or intolerance to antiplatelet, anticoagulant, or thrombolytic drugs; bleeding or coagulation disorders; active peptic ulcer or active gastrointestinal bleeding; pulmonary hypertension > 70 mmHg; creatinine > 2.5 mg/dL; emergent or urgent surgery or planned cardiac surgery (12 months); hepatic insufficiency; life expectancy < 1 year; active infection; pregnancy, breastfeeding, or planning to become pregnant (1 year) Specific to NCT03813524: Primary MR; severe mitral annular calcification; EROA < 0.3 cm2; LVEDD > 75 mm; Elevated creatine kinase MB; eGFR < 30 mL/min/1.73 m2 |
Recruiting (15) NCT03813524 | Technical success and major device related adverse events (30 days) (April 2022) | NCT03813524 and NCT03958773: 85 > age |
Recruiting (10) NCT03958773 | Major device related adverse events (30 days) (12 September 2020) | ≥ 18 years; severe MR; Cardiac Index > 2.0; EF ≥ 30%; NYHA II, III or amb. IV; GDMT (30 days); high surgical risk |
HighLife
(TS) | Recruiting (50) NCT02974881 | MACE at 30 days (July 2021) | Age ≥ 18 years; MR ≥ 3 +; NYHA II, III, amb. IV; GDMT; surgical high-risk; anatomical eligibility; DMR: EROA ≥ 40 mm2 or regurgitant Vol. ≥ 60 mL; SMR: EROA > 30 mm2 or regurgitant Vol. > 45 mL | Stroke/TIA (30 days); symptomatic carotid stenosis > 70%; active infections; active GI bleeding (3 months); bleeding/coagulopathy or refusal of BT; TEE not feasible; pregnant or lactating; allergies (device/contrast medium); anticoagulation or APT unfeasibility; life expectancy < 1 year; PM (3 months) |
Not yet recruiting (15) NCT04029337 | MACE and device safety at 30 days (April 2021) |
Recruiting (50) NCT04029363 | Major adverse events at 30 days (July 2021) |
Tiara
(TA) | Active, not recruiting (115) NCT03039855 | MACE, all-cause mortality, and optimal/acceptable MR reduction at 30 days (January 2021) | Age ≥ 18 years; severe MR; high surgical risk; anatomical eligibility | Previous cardiac procedures; unsuitable cardiac structure; clinically significant untreated CAD; subjects on chronic dialysis; pregnant or planning pregnancy within next 12 months; documented bleeding or coagulation disorders; active infections requiring antibiotic therapy; life expectancy < 12 months
Surgical candidate; prohibitive risk; frail or listed for cardiac transplant; unsuitable anatomy |
Active, not recruiting (30) NCT02276547 | MACE and all-cause mortality at 30 days (6 January 2020) | Age > 18 years; severe MR; high surgical risk; anatomical eligibility; NYHA III or IV HF |
Caisson
(TS) | Active, not recruiting (20) NCT02768402 | MACE at 30 days (September 2023) | Age ≥ 18 years; severe MR; NYHA II, III, IVa or HF; high surgical risk | Excessive calcification or thickened MV annulus; severe MS, fused commissures, or MV vegetation/mass; LVEDD > 7 cm; LVOT obstruction; severe RV dysfunction; stroke (90 days), transient ischemic attack, or MI (30 days) |
Active, not recruiting (75) NCT03661398 | MACE and surgical reintervention at 30 days (August 2025) |
Twelve
(TA) | Active, not recruiting (10) NCT02428010 | Adverse events at 30 days (December 2020) | Age > 18; severe MR 3-4 +; NYHA II-IV; TA access feasible; native and suitable MV anatomy | EF < 20%; intracardiac mass, thrombus, or vegetation; prior MV surgery or need for other valve surgery; stroke (4 weeks); need for CABG; history or active endocarditis; creatinine > 2.5 mg/dL |
Evoque/Fortis (TS) | Recruiting (58) NCT02718001 | Device or Procedural adverse events at 30 days (December 2024) | Significant symptomatic MR; high surgical risk; anatomical eligibility | Unsuitable anatomy; inoperable patient |
AltaValve (TA) | Recruiting (15) NCT03997305 | MACE at 30 days (October 2020) | Age ≥ 18 years; NYHA II-IV; severe MR; high surgical risk | History of any cognitive or mental health status; pregnant or planning pregnancy; hypersensitivity/contraindication to aspirin, heparin, or Warfarin; hypersensitivity to nitinol or contrast media that cannot be adequately medicated; EF ≤ 25%; life expectancy < 12 months; prior MV intervention (excluding prior surgical MV repair, annuloplasty, or MitraClip not interfering with AltaValve placement) |
Mi-thos
(TA) | Not yet recruiting (122) NCT04195984 | Mortality at 1 year (January 2021) | Age > 65; MR ≥3 +; high surgical risk; Life expectancy > 12 months; not eligible for surgery | MV surgery; active infections; clinically significant untreated CAD; pulmonary hypertension; severe RV HF; EF < 25%; hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis; dialysis; severe coagulopathy; contraindications to anticoagulants; stroke or TIA (30 days); intracardiac mass, LV or atrial thrombus; previous intervention on valves; severe macrovascular disease requiring surgery; carotid stenosis > 70%; allergy to contrast agents, nickel–titanium memory alloys, or bovine-derived products; severe neurological disorders affecting cognitive ability; severe thoracic deformities |
SATURN
(TA) | Recruiting (20) NCT04464876 | Device or procedural major adverse events, MR reduction, and technical success at 30 days (December 2021) | Age ≥ 18 years; SMR ≥ 3+; NYHA ≥ II, amb. IV; GDMT; high surgical risk; suitable for quality-of-life assessment (KCCQ) | Frailty or comorbidities; life expectancy < 1 year; active endocarditis or systemic infection; Modified Rankin Scale ≥ 4 disability; hemodialysis/eGFR < 35 mL/min/m2; pulmonary hypertension; COPD on home oxygen; refuses BT; bleeding or coagulation disorders; severe connective tissue disease under chronic immunosuppressive or cortisone therapy; pregnant/ lactating or not willing to take contraceptives; MI (30 days); stroke or TIA (30 days); severe extracardiac arteriopathy; prior MV treatment; mechanical aortic valve or TAVR; need for CV surgery (30 days); CRT or ICD (30 days); hemodynamic instability; CABG or PCI (30 days); need for revascularization; prior or planned heart transplantation; RV HF; unsuitable TA access; hypersensitivity to nickel or titanium; EF ≤ 30%; severe mitral annular calcification; severe MS; MV vegetation or mass; extensive MV flail leaflets; LV thrombus, mass, or vegetation; LV end-diastolic diameter > 7.5 cm; severe RV dysfunction; significant intracardiac shunt; anatomic ineligibility |
Tendyne
(TA) | Active, not recruiting (350) NCT02321514 | Device or procedural adverse events and device malfunction at 30 days (July 2020) | Age ≥ 18 years; severe MR; NYHA ≥ II, amb. IV; high surgical risk | Severe mitral calcification or MS; unsuitable TA access; prior surgical or interventional treatment of mitral or aortic valves |
Recruiting (958) NCT03433274 | HF hospitalization, mortality, CV hospitalization, stroke, and MV reintervention | MR ≥ 3 +; NYHA ≥ II, amb. IV; not a member of a vulnerable population | MV vegetation or mass; EF < 25%; LVEDD > 7 cm; surgical or interventional MV treatment (prosthetic device); aortic valve disease requiring surgery or TC intervention; severe tricuspid regurgitation or needed tricuspid surgery or TC intervention; planned surgical/interventional procedure (60 days); hemodialysis; anatomic unsuitable; life expectancy < 12 months |
Intrepid (TA) | Recruiting (1600) NCT03242642 | Mortality, disabling stroke, reintervention, and CV hospitalization (October 2021) | MR ≥ 3 +; candidate to TMVR | Prior TC MV procedure with device currently implanted; anatomic contraindications; prohibitive mitral annular calcification; EF < 25%; need for emergent or urgent surgery; hemodynamic instability |
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