Optimized Expansion of the Implanted Transcatheter Aortic Valve

NANot yet recruitingINTERVENTIONAL
Enrollment

620

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

July 1, 2032

Study Completion Date

July 1, 2033

Conditions
Aortic Stenosis DiseaseValvular Heart Disease
Interventions
PROCEDURE

OptEx-TAVI

"During TAVI with either self-expanding or balloon-expandable TAVs:~* Pre-dilatation: systematic pre-dilatation with an optimally-sized balloon.~* Post-dilatation: systematic TAV post-dilatation with an optimally-sized balloon.~Optimally-sized balloon:~1. The recommended balloon size used for pre- and post-dilatation is the perimeter-derived mean diameter of the native aortic annulus minus 1 mm and should never exceed the perimeter-derived mean diameter of the native aortic annulus. A smaller-sized balloon should be considered in case of severe left ventricular outflow tract calcium and/or severely calcified leaflets in combination with a shallow sinus of Valsalva.~2. In case of post-dilatation of the Evolut TAV (Medtronic, USA), the instructions for use (IFU) for post-dilatation of the Evolut valve should be respected.~3. Also, a balloon-expandable TAV has to be post-dilated with an optimally-sized balloon in case of randomization to the OptEx-TAVI arm."

PROCEDURE

SoC-TAVI

During TAVI with either self-expanding or balloon-expandable TAVs: Pre-dilatation: optional, as per operator preference and post-dilatation: optional, as per operator preference. Operators are only encouraged to post-dilate the implanted TAV in case of ≥ moderate paravalvular regurgitation or a suboptimal transvalvular gradient. The balloon size used for pre- or post-dilatation is left at the operator's discretion.

Trial Locations (10)

3000

UZ Leuven, Leuven

3435

St. Antonius Hospital, Nieuwegein

5000

Odense University Hospital, Odense C

6000

CHU Charleroi, Charleroi

8200

Skejby Hospital, Aa

9000

Aalborg University Hospital, Aalborg

20520

Turku University Hospital, Turku

Unknown

Rigshospitalet, Copenhagen

0450

Oslo universitetssygehus, Oslo

413 45

Sahlgrenska University Hospital, Gothenburg

All Listed Sponsors
lead

Ole De Backer

OTHER

NCT07042529 - Optimized Expansion of the Implanted Transcatheter Aortic Valve | Biotech Hunter | Biotech Hunter