Clinical trial NCT06470022: Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.
Official title: Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. The Compare-TAVI 2 Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Department of Clinical Epidemiology, Aarhus University, DK-8200 Aarhus N, Denmark
First posted: 2024-06-24
Enrollment: 1346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1
Primary purpose: TREATMENT

Brief summary: To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.

Detailed description: The purpose of the "Compare-TAVI" organization is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances.

Purpose of present study:

To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.

Hypotheses:

1. Evolut FX is non-inferior to Edwards Sapien 3 Resilia with regard to the combined endpoint (death, stroke, moderate/severe aortic regurgitation, moderate/severe valve deterioration) between the two valves being compared.
2. There is no difference between valves in secondary safety and efficacy endpoints (see below)
3. There is no difference in Aortic Regurgitation fraction (ARF) and Effective Orifice Area (EOA) measured by CMR (CMR-substudy, N=166)
4. There is no difference in EOA measured invasively during dobutamine stress (hemodynamic substudy, N=440).
5. There is no difference in occurrence of Hypoathenuated Leaflet Thickening (HALT) measured by CT (CT-substudy, N=778).

Eligibility criteria: Inclusion Criteria:

1. Patient more than 18 years of age.
2. Patient eligible for both Evolut FX and Edwards Sapien 3 Ultra Resilia 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 the treating physician should have implanted at least 15 of each valve 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:

None

Primary outcomes:
measure: Mortality, stroke, moderate/major aortic regurgitation, moderate/severe THV deterioration
timeFrame: 1-year, 3-year, 5-year, 10-year
Secondary outcomes:
measure: TAVI-related complications
timeFrame: 7-days
measure: Proportion with successful implantation of the chosen valve.
timeFrame: 7-days
measure: SMART criteria for bioprosthetic valve dysfunction through 12 months
timeFrame: 1-year
measure: Pacemaker-implantation
timeFrame: 1-year
measure: Vascular and access-related complications (exploratory only)
timeFrame: 30-days
measure: Bleeding and transfusion (exploratory only)
timeFrame: 30-days
measure: Endocarditis (exploratory only)
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year
measure: Reoperation (exploratory only)
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year
measure: Moderate/severe prosthesis-patient mismatch (exploratory only)
timeFrame: 30-day
measure: Mean gradient (exploratory only)
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year
measure: Pacemaker-implantation (exploratory only)
timeFrame: 30-day prior to TAVI, 30-day, 1-year, 3-year, 5-year, 10-year
measure: Readmission for congestive heart failure (exploratory only)
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year.
measure: AMI (exploratory only)
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year.
measure: Revascularization (exploratory only)
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year.
measure: Atrial fibrillation (exploratory only)
timeFrame: 30-day, 1-year, 3-year, 5-year, 10-year.
measure: Kidney injury (exploratory only)
timeFrame: 30-day
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of cardiology, Aarhus University Hospital
Study officials:
affiliation: Department of cardiology, Aarhus University Hospital, DK-8200 Aarhus N, Denmark
name: christian J Terkelsen, Professor
role: PRINCIPAL_INVESTIGATOR
References: