Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.
NCT Number: NCT06470022
Acronym: COMPARE-TAVI
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aortic Stenosis
Interventions: DEVICE: Medtronic Evolut FX|DEVICE: Edwards Sapien 3 Ultra Resilia
Sponsor: Christian Juhl Terkelsen
Collaborators: Department of Clinical Epidemiology, Aarhus University, DK-8200 Aarhus N, Denmark
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1346
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-09
Completion Date: 2036-12-01
Locations: Department of cardiology, Aarhus University Hospital, Aarhus, 8200, Denmark

Summary:
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.

Primary Outcome Measures: Mortality, stroke, moderate/major aortic regurgitation, moderate/severe THV deterioration, The primary composite endpoint is at one-year, and a non-inferiority test is performed. See separate statistical analysis plan. Separate analyses of each component of the primary outcome will be presented, in accordance with the FDA guidelines and EMA guidelines, i.e. mortality, stroke, moderate/severe aortic regurgitation and moderate/severe THV deterioration to better understand their contribution to the primary endpoint. If non-inferiority is proven for the primary composite endpoint, a split alfa is used to test for superiority if possible (alfa=0.025) and to test secondary safety and efficacy endpoints (Total alfa=0.025 for these). The composite endpoint will be re-analyzed after 3-, 5- and 10-year as superiority analyses., 1-year, 3-year, 5-year, 10-year
Secondary Outcome Measures: TAVI-related complications, conversion to open surgery during implantation, unplanned use of cardiopulmonary support (CPS), coronary artery obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade / pericardial effusion resulting in pericardiocentesis, valve embolization, valve migration, need for TAVI-in-TAVI deployment, using VARC-3 criteria 10, or annulus rupture, aortic rupture/perforation, aortic dissection, or other shunts than VSD., 7-days|Proportion with successful implantation of the chosen valve., This means no need for more than 1 TAVI valve, no change to another valve than planned during the procedure because it was impossible to implant the valve planned, and no conversion to surgery or procedure-related death., 7-days|SMART criteria for bioprosthetic valve dysfunction through 12 months, composed of the following components: (1) hemodynamic structural valve dysfunction, defined as aortic valve mean gradient ≥ 20 mmHg at any time up to the 12-month visit echo; (2) nonstructural valve dysfunction, defined as severe prosthesis-patient mismatch or ≥ moderate total aortic regurgitation at any time up to the 12-month visit echo; (3) clinical valve thrombosis; (4) endocarditis; or (5) aortic valve reintervention., 1-year|Pacemaker-implantation, New pace-maker implantation in pacemaker-naive patients., 1-year|Vascular and access-related complications (exploratory only), Major vascular access site and access-related complications resulting in endovascular or open surgery using VARC-3 criteria, 30-days|Bleeding and transfusion (exploratory only), Major bleeding resulting in drop in hgb-level ≥1.86 mmol/l and/or erythrocyte transfusion ≥ 2 units, modified from BARC type 3-5 criteria, 30-days|Endocarditis (exploratory only), According to VARC-3 criteria., 30-day, 1-year, 3-year, 5-year, 10-year|Reoperation (exploratory only), Transcatheter Aortic Valve Intervention, Surgical Aortic Valve Intervention or Balloon Angioplasty, 30-day, 1-year, 3-year, 5-year, 10-year|Moderate/severe prosthesis-patient mismatch (exploratory only), Effective Orifice Area (EOA)/body surface area ≤0.85 cm2/m2 if BMI\<30 kg/cm2 or \<=0.70 cm2/m2 if BMI\>=30 kg/cm2., according to VARC-3 criteria., 30-day, 1-year, 3-year, 5-year,10-year|Mean gradient (exploratory only), Aortic mean gradient, mmHg, as evaluated by Echocardiograpy Core-laboratory., 30-day, 1-year, 3-year, 5-year, 10-year|Pacemaker-implantation (exploratory only), New pacemaker in pacemaker naive-patients., 30-day prior to TAVI, 30-day, 1-year, 3-year, 5-year, 10-year|Readmission for congestive heart failure (exploratory only), Adjudicated. Only monitored until first confirmed case., 30-day, 1-year, 3-year, 5-year, 10-year.|AMI (exploratory only), Acute Myocardial Infarction. Adjudicated. Only monitored until first confirmed case., 30-day, 1-year, 3-year, 5-year, 10-year.|Revascularization (exploratory only), PCI (Percutaneous coronary intervention) CABG (Coronary Artery Bypass Grafting), not scheduled before TAVI, 30-day, 1-year, 3-year, 5-year, 10-year.|Atrial fibrillation (exploratory only), Newly diagnosed atrial fibrillation/flutter, 30-day, 1-year, 3-year, 5-year, 10-year.|Kidney injury (exploratory only), Increase in renal creatinine level more than to ≥200% (AKIN stage 2-3, VARC-3 criteria) or resulting in dialysis (AKIN stage 4) according to VARC-3 criteria., 30-day