Optimized Expansion of the Implanted Transcatheter Aortic Valve

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-05

Study Completion Date

2033-07-01

Brief Summary

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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.

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Detailed Description

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A total of 620 patients will be included in the OptEx-TAVI trial and randomised 1:1 to either :

* SoC-TAVI (N = 310) or
* OptEx-TAVI (N = 310)

All patients with indication for TAVI and eligible in relation to the study in- and exclusion criteria will be offered participation in the OptEx-TAVI trial.

Inclusion criteria:

* Severe symptomatic aortic stenosis patients with an 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, 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

Baseline characteristics, medical history, procedural details, electrocardiogram, echocardiography and cardiac CT-scan parameters will be recorded by assessing medical charts and patient interview.

During the TAVI-procedure, patients will be treated according to randomisation to either SoC or OptEx

Planned post-procedural visits at:

* Discharge: on-site - including transthoracic echocardiography (TTE)
* 3 months visit (± 2 months): on-site - including TTE and cardiac CT scan
* 1 year (± 3 months): on-site - including TTE and cardiac CT scan
* 5 years (± 6 months): on-site - including TTE and cardiac positron emission tomography (PET)-CT scan

Conditions

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Aortic Stenosis Disease Valvular Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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SoC-TAVI

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.

Group Type ACTIVE_COMPARATOR

SoC-TAVI

Intervention Type 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.

OptEx-TAVI

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

Group Type EXPERIMENTAL

OptEx-TAVI

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Severe symptomatic aortic stenosis patients with an 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, 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ole De Backer

Professor of Cardiologi, Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ole De Backer, MD, PhD, FESC

Role: PRINCIPAL_INVESTIGATOR

The Heart Center, Rigshospitalet

Locations

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