Optimized Expansion of the Implanted Transcatheter Aortic Valve
Recruiting
N/A
Interventional Study
Aortic Stenosis Disease
Valvular Heart Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,010 (estimated)
- Sponsor
- Ole De Backer · Other
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About This Trial
Optimized Expansion of the implanted transcatheter aortic valve to reduce hypoattenuating leaflet thickening in non-atrial fibrillation patients undergoing transcatheter aortic valve implantation (TAVI): an international, multicentre, randomized controlled trial.
The objective is to evaluate whether TAVI with systematic optimized pre- and post-dilatation (optimized expansion (OptEx) TAVI strategy…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Severe native aortic valve stenosis
* Indication for TAVI
* Ability to understand and to comply with the study protocol
Exclusion Criteria:
* Existing indication for oral anticoagulation (e.g., atrial fibrillation, venous thromboembolism, antiphospholipid syndrome, mechanica…
Contacts