Comparing balloon and self-expanding valves for heart valve replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 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 EVOLUT, SAPIEN or MYVAL THV series
* 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 it's running

• Cedars Sinai
  Los Angeles, California, United States Recruiting
• Vienna General Hospital
  Vienna, Austria Recruiting
• Institut Cœur Poumon
  Lille, France Recruiting
• Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany
  Düsseldorf, Germany Recruiting
• Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece
  Athens, Greece Recruiting
• Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Institute, Brescia, Italy
  Brescia, Italy 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.