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Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve

Recruitingn/aAges 18 Years - anyAllInstitut für Pharmakologie und Präventive Medizin
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In plain words

What the trial is, and whether it could suit you

Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.

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📋 Eligibility rules (as published)
Inclusion criteria: * Adult patients (≥18 years) * Patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve * Patient is willing to attend the follow-up visits up to 10 years at the center Exclusion criteria: * Lack of written informed consent * Emergency procedure * Pregnancy at time of TAVI Critieria for long-term observation (1y-10y): * Technical success at exit from procedure room (VARC-3): * Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device (excluding permanent pacemaker or PTA and stenting without major bleeding) or to a major vascular or access related, or cardiac structural complication * Absence of the following severe procedural and in-hospital complications (VARC-3 definitions): * All stroke * Bleeding type 3-4 * Myocardial infarction * Need for a second valve * Valve embolization * Coronary obstruction * Annular rupture
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What it tests

  • Transcatheter aortic valve (S3UR) replacement (TAVR)
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Where

1 site
Heart and Diabetes Center North Rhine-Westphalia
Bad Oeynhausen, Germany
🤝 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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