Clinical trial NCT04443023: Comparison of Eligible TAVI-valves - Cohort B
Official title: Randomized Comparison of Eligible TAVI-valves - Cohort B (Sapien Versus Myval)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Transcatheter Aortic Valve Implantation
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Aalborg University Hospital
First posted: 2020-06-23
Enrollment: 1031
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with MACE (Major Adverse Cardiovascular Events)
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of patients with MACE
timeFrame: 30 day, 3-year, 5-year and 10-year
measure: Percentage death
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year
measure: Percentage of patients with stroke
timeFrame: During admission, 30-day, 1-year, 3-year, 5-year, 10-year
measure: Percentage of patients with moderate or severe paravalvular leakage
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year
measure: Percentage of patients with moderate/major aortic stenosis
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year
measure: Percentage of patients with new pacemaker
timeFrame: During admission, 30-day, 1-year, 3-year, 5-year, 10-year
measure: Percentage of patients with major bleeding
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year
measure: Distance in meters during 6-minute walk test
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year
measure: Percentage of patients with other TAVI-related complications
timeFrame: During TAVI-procedure
measure: Percentage of patients with endocarditis
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year
measure: Proportion with successful implantation of the chosen valve.
timeFrame: During procedure
measure: Percentage of patients with major vascular access site and access-related complications
timeFrame: During admission and 30-day
measure: Percentage of patients with valve thrombosis or severe stenosis
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year
measure: Percentage of patients with readmission with congestive heart failure
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year
measure: Percentage of patients with increase in creatinin level of 100% or more, or dialysis
timeFrame: during admission and within 30 days
measure: Percentage of patients with moderate/severe PVL stratified according to level of annular calcium on HCT in three groups
timeFrame: 30-day
measure: Mean Gradient (AO) stratified according to level of annular calcium on HCT in three groups
timeFrame: 30-day
measure: Percentage of patients with prosthesis-patient mismatch
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year
measure: Mean effective orifice area measured by MRI
timeFrame: 30-day
measure: Percentage of patients with leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT
timeFrame: 30-day and 1-year
measure: Mean volume of aortic regurgitation measured by MRI
timeFrame: 30-day
measure: Other tavi-related complications
timeFrame: 30-day
measure: AMI
timeFrame: 30-day, 1-year, 3-year, 5-year and 10-year
measure: PCI og CABG
timeFrame: 30-day, 1-year, 3-year, 5-year and 10-year
measure: Reopeation
timeFrame: 30-day, 1-year, 3-year, 5-year and 10-year
measure: Afib
timeFrame: 30-day, 1-year, 3-year, 5-year and 10-year.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: odense univeristy hospital
name: henrik nissen, PhD
role: STUDY_CHAIR
References:
citation: Terkelsen CJ, Thim T, Freeman P, Dahl JS, Norgaard BL, Kim WY, Tang M, Sorensen HT, Christiansen EH, Nissen H. Randomized comparison of TAVI valves: The Compare-TAVI trial. Am Heart J. 2024 Aug;274:84-94. doi: 10.1016/j.ahj.2024.05.003. Epub 2024 May 9.