Optimized Expansion of the Implanted Transcatheter Aortic Valve (OptEx-TAVI)

Ole De Backer

Status: Enrolling

Conditions: Valvular Heart Disease; Aortic Stenosis Disease

Treatments: Procedure: SoC-TAVI; Procedure: OptEx-TAVI

Study type: Interventional

Funder types: Other

Identifiers

NCT07042529

OptEx-TAVI Trial

H-25039123 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 620 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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620 participants in 2 patient groups

SoC-TAVI

Active Comparator group

Description:

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.

Treatment:

Procedure: SoC-TAVI

OptEx-TAVI

Experimental group

Description:

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

Treatment:

Procedure: OptEx-TAVI