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ClinicalTrials.gov ID

NCT07042529

Lead Sponsor

Ole De BackerOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,010Estimated

Last Update Posted

Jul 10, 2026Actual

Start Date

Oct 5, 2025Actual

Primary Completion Date

Jul 1, 2029Estimated

Completion Date

Jul 1, 2033Estimated

Official Title

Optimized Expansion of the Implanted Transcatheter Aortic Valve to Reduce Hypoattenuating Leaflet Thickening in Non-atrial Fibrillation Patients Undergoing Transcatheter Aortic Valve Implantation: an International, Multicentre, Randomized Controlled Trial

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.

Detailed Description

A total of 1010 patients will be included in the OptEx-TAVI trial and randomised 1:1 to either :

• SoC-TAVI (N = 505) or
• OptEx-TAVI (N = 505)

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 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, 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

• Aortic Stenosis Disease
• Valvular Heart Disease

• OptEx-TAVI
• SoC-TAVI

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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, 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Ole De BackerOTHER

Maarten.Vanhaverbeke@azdelta.be+32 51 23 61 11