Comparison of Eligible TAVI-valves - Cohort B (Compare-TAVI)

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

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

Study Overview

• Status: Recruiting
• Conditions: Transcatheter Aortic Valve Implantation
• Intervention / Treatment: Device: chosen TAVI valve

Detailed Description

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
• Enrollment (Estimated): 1062
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: christian j terkelsen, Professor; Phone Number: 004587452017; Email: chriterk@rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: christian juhl J terkelsen; Phone Number: 24288571; Email: chriterk@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient more than 18 years of age.
2. Patient eligible for at least 2 valves being implanted routinely at the participating center, according to a TAVI heart team conference.
3. 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.
4. The center volume should be more than 75 cases a year.
5. The patient has given signed informed consent.
6. TAVI performed via the femoral artery.

Exclusion Criteria:

1. Not able to give written inform consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sapien; Patients randomized to treatment	Device: chosen TAVI valve; chosen TAVI valve
Active Comparator: Myval; Patients randomized to treatment	Device: chosen TAVI valve; chosen TAVI valve

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Collaborators: Odense University Hospital; Aalborg University Hospital
• Investigators: Study Chair: henrik nissen, PhD, Odense Univeristy Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): November 2, 2023
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: June 7, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Compare-TAVI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Normally this will be possible when data are published and anonymized. Mainly to support meta-analysis on individual level data.
• IPD Sharing Time Frame: When endpoints are published in an international peer-reviewed paper
• IPD Sharing Access Criteria: To share data there shall be a well-defined purpose. This could be to contribute to a meta-analysis on individual level data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No