Optimized Expansion of the Implanted Transcatheter Aortic Valve

NCT07042529 | Recruiting DMC

• 2 other identifiers: OptEx-TAVI TrialH-25039123
• Study Type: interventional
• Target: 620
• Locations: 6 countries
• Sites: 10

Brief Summary

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), compared to a standard of care (SoC) TAVI strategy, is superior in reducing hypoattenuating leaflet thickening as evaluated by cardiac computed tomography (CT) imaging at three months after TAVI. The primary outcome is at least one thickened TAV leaflet involving ≥ 25% of the leaflet curvilinear dimension as assessed at cardiac CT at three months after TAVI.

Conditions

Aortic Stenosis Disease; Valvular Heart Disease

Keywords

Aortic stenosis; Cardiovascular; Transcatheter aortic valve; Transcatheter aortic valve implantation; Valvular heart disease; TAVI

Outcome Measures

Primary Outcomes (1)

• At least one TAV leaflet with HALT

  At least one TAV leaflet with hypoattenuated leaflet thickening (HALT) involving more than the base (≥ 25% of the leaflet curvilinear dimension) as assessed at cardiac CT-scan .

  At three months after TAVI

Secondary Outcomes (26)

• HALT 50%

  At 3 months/At 1 year

• HALT 25%

  At 3 months/At 1 year

• HALT 50%, multiple

  At 3 months/At 1 year

• Bioprosthetic leaflet micro-calcification target-to-background ratio

  At 5 years

• Valve performance

  At 3 months/At 1 year

Study Arms (2)

SoC-TAVI

ACTIVE COMPARATOR

Pre-dilatation and post-dialation optional, as per operator preference. The balloon size used for pre- or post-dilatation is left at the operator's discretion. Operators are only encouraged to post-dilate the implanted transcatheter aortic valve (TAV) in case of ≥ moderate paravalvular regurgitation or a suboptimal transvalvular gradient.

Procedure: SoC-TAVI

OptEx-TAVI

EXPERIMENTAL

Systematic pre-dilatation and post-dilatation with an optimally-sized balloon

Procedure: OptEx-TAVI

Interventions

OptEx-TAVI PROCEDURE

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.

OptEx-TAVI

SoC-TAVI PROCEDURE

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.

SoC-TAVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe symptomatic aortic stenosis patients with an indication for TAVI
• Ability to understand and to comply with the study protocol

You may not qualify if:

• Existing indication for oral anticoagulation (e.g., atrial fibrillation, venous thromboembolism, antiphospholipid syndrome, mechanical mitral valve)
• Creatinine clearance \<15 mL/min (CKD-EPI formula) or on renal replacement therapy
• Iodine contrast allergy or other condition that prohibits cardiac CT imaging

Sponsors & Collaborators

• Ole De Backer: lead

Study Sites (10)

CHU Charleroi

Charleroi, 6000, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

Skejby Hospital

Aa, 8200, Denmark

NOT YET RECRUITING

Aalborg University Hospital

Aalborg, 9000, Denmark

NOT YET RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Odense University Hospital

Odense C, 5000, Denmark

NOT YET RECRUITING

Turku University Hospital

Turku, 20520, Finland

NOT YET RECRUITING

St. Antonius Hospital

Nieuwegein, 3435, Netherlands

NOT YET RECRUITING

Oslo universitetssygehus

Oslo, 0450, Norway

NOT YET RECRUITING

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction

Study Officials

• Ole De Backer, MD, PhD, FESC

  The Heart Center, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ole De Backer, MD, PhD, FESC

CONTACT

+4535457086; ole.de.backer@regionh.dk

Troels H Jørgensen, MD, PhD

CONTACT

+4535450892; troels.hoejsgaard.joergensen.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Cardiologi, Principal investigator

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 29, 2025
• Study Start: October 5, 2025
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): July 1, 2033
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); BE (2); FI (1); NL (1); SE (1); DK (4)