Comparing two heart valve treatments for aortic stenosis
Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. The Compare-TAVI 2 Trial
This study is testing whether the Evolut FX heart valve works just as well as the Sapien 3 Ultra Resilia valve for treating aortic stenosis in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1346 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Skejby Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT06470022 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the outcomes of patients receiving either the Evolut FX or the Sapien 3 Ultra Resilia heart valves for the treatment of aortic stenosis. Patients will be randomized to receive one of the two valve types, and their health outcomes will be monitored over time. The study will assess various endpoints, including death, stroke, and valve performance, to determine if the Evolut FX valve is non-inferior to the Sapien 3 Ultra Resilia. Additionally, secondary safety and efficacy endpoints will be evaluated through various substudy methodologies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are eligible for both valve types as determined by a TAVI heart team.
Not a fit: Patients who are not eligible for either the Evolut FX or Sapien 3 Ultra Resilia valves will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective heart valve treatment for patients with aortic stenosis, potentially improving patient outcomes.
How similar studies have performed: Other studies comparing different TAVI valves have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarhus
- Department of cardiology, Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: christian J Terkelsen, Professor — Department of cardiology, Aarhus University Hospital, DK-8200 Aarhus N, Denmark
- Study coordinator: Christian J Terkelsen, Professor
- Email: CHRITERK@RM.DK
- Phone: +4540135388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.