The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.
The purpose of the present study is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances. Purpose: To randomize between two TAVI-valve types in patients who according to a heart team conference is found eligible for treatment with more than one valve. Hypotheses: 1. There is no difference in the combined endpoint (death, stroke, moderate/severe para-valvular leakage, moderate/severe device stenosis) between the two valves to be compared. 2. There is no difference between valves in secondary endpoints: death, stroke, moderate/major paravalvular leakage, moderate/severe aortic device stenosis, new pacemaker implantation, readmission for congestive heart failure, 6-minute walk test, and degeneration of the valve as evaluated by computerized tomography (HCT), transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), or MRI. Design: Randomized controlled trial with clinical national registry follow-up. Centers eligible for inclusion: Scandinavian and European centers who fulfill the above mentioned criteria. Randomization: Before randomizing patients, the center decides which two valves the patient is found eligible for, and enters these valves in the electronic randomization form (TrialPartner). Randomization is then performed between these two valves. A patient is only randomized if a dedicated technical TAVI conference has found the patient eligible for treatment with both valves. Consecutive cohorts are established. In the current study we plan to initiate the following cohorts: Cohort B: Patients randomized to the Sapien or the Myval TAVI valve. Operator requirements: Any procedure requires that the physician has performed at least 15 implantations with the valve in use. Otherwise the procedure is performed according to the routine of the institution.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,031
chosen TAVI valve
Aarhus University Hospital
Aarhus, Denmark
Percentage of patients with MACE (Major Adverse Cardiovascular Events)
Mortality, stroke, moderate/major PVL, moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria
Time frame: 1 year
Percentage of patients with MACE
Mortality, stroke, moderate/major paravalvular leakage (PVL), moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria
Time frame: 30 day, 3-year, 5-year and 10-year
Percentage death
Mortality
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with stroke
According to Valve Academic Research Consortium (VARC)-3 criteria
Time frame: During admission, 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with moderate or severe paravalvular leakage
Moderate or severe paravalvular leakage according to VARC-3 criteria
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with moderate/major aortic stenosis
According to VARC-3 criteria
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with new pacemaker
New Pacemaker after TAVI-procedure
Time frame: During admission, 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with major bleeding
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Major bleeding according to Bleeding Academic Research Consortium (BARC) type 3 or 5 criteria, resulting in either a drop in Hbg\>=1.86 mmol/l or \>=2 units of blood transfusion
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Distance in meters during 6-minute walk test
6-minute walk test
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with other 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, valve thrombosis, valve embolization, valve migration, need for TAVI-in-TAVI deployment, using VARC-3 criteria
Time frame: During TAVI-procedure
Percentage of patients with endocarditis
Endocarditis
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
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.
Time frame: During procedure
Percentage of patients with major vascular access site and access-related complications
According to VARC-3 criteria
Time frame: During admission and 30-day
Percentage of patients with valve thrombosis or severe stenosis
Valve thrombosis or severe stenosis confirmed by Echo or HCT
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with readmission with congestive heart failure
Readmission with congestive heart failure
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Percentage of patients with increase in creatinin level of 100% or more, or dialysis
Increase in renal creatinine level more than to \>=200% (AKIN stage 2-3, VARC-3 criteria) or dialysis
Time frame: during admission and within 30 days
Percentage of patients with moderate/severe PVL stratified according to level of annular calcium on HCT in three groups
Severity of PVL stratified according to level of annular calcium on HCT (low/medium/high)
Time frame: 30-day
Mean Gradient (AO) stratified according to level of annular calcium on HCT in three groups
Gradient (AO) stratified according to level of annular calcium on HCT (low/medium/high)
Time frame: 30-day
Percentage of patients with prosthesis-patient mismatch
Prosthesis-patient mismatch (EOA/body surface area). Severe PPM≤0.65 cm2/m2. Moderate PPM≤0.85 cm2/m2 according to VARC-3 criteria
Time frame: 30-day, 1-year, 3-year, 5-year, 10-year
Mean effective orifice area measured by MRI
Effective orifice area measured by MRI in patients participating in MRI-substudy
Time frame: 30-day
Percentage of patients with leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT
Leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT in patients participating in HCT-substudy
Time frame: 30-day and 1-year
Mean volume of aortic regurgitation measured by MRI
Volume of aortic regurgitation measured by MRI in patients participating in MRI-substudy
Time frame: 30-day
Other tavi-related complications
Anulus rupture or aortic rupture
Time frame: 30-day
AMI
Acute Myocardial Infarction
Time frame: 30-day, 1-year, 3-year, 5-year and 10-year
PCI og CABG
Percutaneous Coronary Intervention or coronary artery bypass grafting
Time frame: 30-day, 1-year, 3-year, 5-year and 10-year
Reopeation
Reopeation with TAVI, Surgical ortic valve replacement (SAVR) or BAV (Balloon aortic valvuloplasty) according to VARC-3 criteria
Time frame: 30-day, 1-year, 3-year, 5-year and 10-year
Afib
Newly diagnosed atrial fibrillation according to VARC-3 criteria
Time frame: 30-day, 1-year, 3-year, 5-year and 10-year.