🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

RecruitingNAAges 18 Years - anyAllErasmus Medical Center
NCT04843072 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements are performed using a bioprosthesis. Durability of surgical bioprostheses varies according to patient age at the time of implantation, prosthesis type and size, among other factors. TAVI has become an established treatment option for patients with a degenerated surgical aortic bioprosthesis. The time from index surgical aortic valve replacement (SAVR) to bioprosthetic valve degeneration is typically 8-10 years. TAVI in this setting has shown favorable outcomes. Balloon-expandable and self-expanding transcatheter heart valves (THVs) can both be used for the treatment of a degenerated surgical aortic bioprosthesis and have specific advantages and limitations. Valve-in-valve TAVI may be associated with coro

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • EVOLUT R/PRO/PRO+/FX bioprosthesis
  • Edwards Sapien S3/Ultra bioprosthesis
  • MYVAL/Octacor/Octapro bioprosthesis
📍

Where

14 sites
Cedars Sinai
Los Angeles, United States
Vienna General Hospital
Vienna, Austria
St Paul's and Vancouver General Hospital
Vancouver, Canada
Rigshospitalet
Copenhagen, Denmark
Institut Cœur Poumon
Lille, France
Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany
Düsseldorf, Germany
University Hospital Mainz
Mainz, Germany
Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece
Athens, Greece

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy