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The ReTAVI Prospective Observational Registry

Recruitingn/aAges 18 Years - anyAllInstitut für Pharmakologie und Präventive Medizin
NCT05601453 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure. The evidence on redo-TAVI (where a transcatheter heart valve \[THV\] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations. Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year, 3 years and 5 years.

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📋 Eligibility rules (as published)
Inclusion Criteria: Consecutive patients fulfilling the following criteria: 1. Consenting adult patient (≥18 years) 2. Procedural success of the first TAVI 3. TAVI device failure of the index THV, irrespective of SVD severity 4. Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV) 5. The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI 6. Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital) Exclusion Criteria: 1. Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC) 2. Life expectancy below 12 months 3. Patients with largely incomplete data with respect to the aims of the project 4. Pregnant women at the time of the redo-TAVI Note: For all patients included a defined core data set will be collected prospectively. All patients being in accordance with above stated inclusion and exclusion criteria and receiving a balloon-expandable transcatheter aortic valve will be included in the extended documentation.
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What it tests

  • Elective redo transcatheter aortic valve implantation (redo-TAVI)
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Where

62 sites
LKH-University Hospital and Medical University of Graz
Graz, Austria
Kepler University Clinic Linz
Linz, Austria
University Hospital St. Pölten
Sankt Pölten, Austria
Medical University of Vienna
Vienna, Austria
McGill University Health Centre
Montreal, Canada
Institut Universitaire de Cardiologie et de Pneumologie
Québec, Canada
St. Paul's Hospital, Vancouver
Vancouver, Canada
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France

…and 54 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.
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