Comparison of Eligible TAVI-valves - Cohort B

Study Overview
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Brief Summary
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The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.

Detailed Description
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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: 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. 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.

Official Title
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Randomized Comparison of Eligible TAVI-valves - Cohort B (Sapien Versus Myval)

Conditions
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Transcatheter Aortic Valve Implantation

Intervention / Treatment
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* Device: chosen TAVI valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient more than 18 years of age. Patient eligible for at least 2 valves being implanted routinely at the participating center, according to a TAVI heart team conference. The center experience for each of the valves considered should be more than 15 cases a year, and at least 15 valves implanted before a valve can be used in the trial. The center volume should be more than 75 cases a year. The patient has given signed informed consent. TAVI performed via the femoral artery. Exclusion Criteria: 1. Not able to give written inform consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sapien<br>Patients randomized to treatment | Device: chosen TAVI valve<br>* chosen TAVI valve<br>|
| Active Comparator: Myval<br>Patients randomized to treatment | Device: chosen TAVI valve<br>* chosen TAVI valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with MACE | Mortality, stroke, moderate/major paravalvular leakage (PVL), moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria | 30 day, 3-year, 5-year and 10-year | 
| Percentage death | Mortality | 30-day, 1-year, 3-year, 5-year, 10-year | 
| Percentage of patients with stroke | According to Valve Academic Research Consortium (VARC)-3 criteria | 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 | 30-day, 1-year, 3-year, 5-year, 10-year | 
| Percentage of patients with moderate/major aortic stenosis | According to VARC-3 criteria | 30-day, 1-year, 3-year, 5-year, 10-year | 
| Percentage of patients with new pacemaker | New Pacemaker after TAVI-procedure | During admission, 30-day, 1-year, 3-year, 5-year, 10-year | 
| Percentage of patients with major bleeding | 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 | 30-day, 1-year, 3-year, 5-year, 10-year | 
| Distance in meters during 6-minute walk test | 6-minute walk test | 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 | During TAVI-procedure | 
| Percentage of patients with endocarditis | Endocarditis | 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. | During procedure | 
| Percentage of patients with major vascular access site and access-related complications | According to VARC-3 criteria | During admission and 30-day | 
| Percentage of patients with valve thrombosis or severe stenosis | Valve thrombosis or severe stenosis confirmed by Echo or HCT | 30-day, 1-year, 3-year, 5-year, 10-year | 
| Percentage of patients with readmission with congestive heart failure | Readmission with congestive heart failure | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 30-day | 
| Other tavi-related complications | Anulus rupture or aortic rupture | 30-day | 
| AMI | Acute Myocardial Infarction | 30-day, 1-year, 3-year, 5-year and 10-year | 
| PCI og CABG | Percutaneous Coronary Intervention or coronary artery bypass grafting | 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 | 30-day, 1-year, 3-year, 5-year and 10-year | 
| Afib | Newly diagnosed atrial fibrillation according to VARC-3 criteria | 30-day, 1-year, 3-year, 5-year and 10-year. |