Comparing balloon and self-expanding valves for heart valve replacement
Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis. THE BASELINE TRIAL.
This study is testing whether balloon-expandable or self-expanding heart valves work better for older patients needing a replacement due to a failed heart valve.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 14 sites (Los Angeles, California and 13 other locations) |
| Trial ID | NCT04843072 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of balloon expandable versus self-expanding transcatheter heart valves in patients with degenerated surgical aortic bioprostheses. It focuses on elderly patients who require valve replacement due to bioprosthesis failure, utilizing a transfemoral TAVI approach. The study aims to assess the safety and efficacy of these two valve types in preventing complications associated with valve replacement. Participants will be selected based on multi-modality imaging assessments and heart team consensus.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 and older with failing surgical aortic bioprostheses who are eligible for transfemoral TAVI.
Not a fit: Patients with multi-valve defects, unstable clinical conditions, or those with a mechanical aortic valve will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for elderly patients with degenerated aortic bioprostheses.
How similar studies have performed: Other studies have shown promising results with transcatheter aortic valve implantation in similar patient populations, indicating that this approach is both effective and increasingly utilized.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 65 years * Failing surgical aortic bioprosthesis requiring valve replacement and eligible for transfemoral TAVI with balloon expandable or self-expanding platform per heart team consensus based on multi-modality imaging assessment (including echocardiography and multidetector CT). * Written informed consent Exclusion Criteria: * Not eligible for Transfemoral TAVI with SAPIEN-3 / Ultra and Evolut R/Pro * Multi-valve defects requiring intervention * Clinically unstable and/or inotropic/vasopressor /mechanical support. * Known mural thrombus in the left ventricle * Presence of a mechanical aortic valve * History of recent (within 1 month) stroke or TIA
Where this trial is running
Los Angeles, California and 13 other locations
- Cedars Sinai — Los Angeles, California, United States (Not_yet_recruiting)
- Vienna General Hospital — Vienna, Austria (Not_yet_recruiting)
- St Paul's and Vancouver General Hospital — Vancouver, Canada (Not_yet_recruiting)
- Rigshospitalet — Copenhagen, Denmark (Not_yet_recruiting)
- Institut Cœur Poumon — Lille, France (Not_yet_recruiting)
- Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany — Düsseldorf, Germany (Recruiting)
- University Hospital Mainz — Mainz, Germany (Not_yet_recruiting)
- Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece — Athen, Greece (Recruiting)
- Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Institute, Brescia, Italy — Brescia, Italy (Recruiting)
- University Hospital of Padova — Padua, Italy (Not_yet_recruiting)
- Erasmus Medical Centre — Rotterdam, Netherlands (Recruiting)
- Centro Hospitalar de Lisboa Ocidental — Lisbon, Portugal (Not_yet_recruiting)
- Inselspital, University Hospital — Bern, Switzerland (Not_yet_recruiting)
- Leeds Teaching Hospitals — Leeds, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Nicolas Van Mieghem, MD, PhD — Erasmus Medical Centre
- Study coordinator: Rutger-Jan Nuis, MD, PhD
- Email: r.nuis@erasmusmc.nl
- Phone: +31614858291
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.