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

Aarhus University Hospital Skejby

Status: Active, not recruiting

Conditions: Transcatheter Aortic Valve Implantation

Treatments: Device: chosen TAVI valve

Study type: Interventional

Funder types: Other

Identifiers

NCT04443023

Compare-TAVI

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,031 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,031 participants in 2 patient groups

Sapien

Active Comparator group

Description:

Patients randomized to treatment

Treatment:

Device: chosen TAVI valve

Myval

Active Comparator group

Description:

Patients randomized to treatment

Treatment:

Device: chosen TAVI valve