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

July 8, 2026 updated by: Ole De Backer

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

1010

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Experimental: OptEx-TAVI
Systematic pre-dilatation and post-dilatation with an optimally-sized balloon
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
At least one TAV leaflet with HALT
Time Frame: At three months after TAVI
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
HALT 50%
Time Frame: At 3 months/At 1 year
At least one TAV leaflet with HALT involving ≥ 50% of the leaflet curvilinear dimension assessed by cardiac CT-scan
At 3 months/At 1 year
HALT 25%
Time Frame: At 3 months/At 1 year
The rate of TAV leaflets with HALT involving ≥ 25% of the leaflet curvilinear dimension assessed by cardiac CT-scan
At 3 months/At 1 year
HALT 50%, multiple
Time Frame: At 3 months/At 1 year
The rate of TAV leaflets with HALT involving ≥ 50% of the leaflet curvilinear dimension assessed by cardiac CT-scan
At 3 months/At 1 year
Bioprosthetic leaflet micro-calcification target-to-background ratio
Time Frame: At 5 years

Ratio of bioprosthetic micro-calcification activity assessed by PET CT- scan by 18F-NaF uptake originating from the valve leaflets observed on 3 orthogonal planes after co-registration of background PET activity with contrast CT angiography.

Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan
At 5 years
Valve performance
Time Frame: At 3 months/At 1 year
Intended performance of the valve (mean gradient < 20 mmHg, peak velocity < 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation) by TTE as per VARC- 3 criteria
At 3 months/At 1 year
structural valve deterioration
Time Frame: At 5 years
Moderate or greater hemodynamic structural valve deterioration by TTE as per VARC-3 criteria. Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan
At 5 years
Bioprosthetic valve dysfunction (BVD)
Time Frame: At 5 years
Severe bioprosthetic valve dysfunction (BVD) by TTE as per VARC-3 criteria. Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan
At 5 years
Bioprosthetic valve failure (BVF)
Time Frame: At 5 years
As per VARC-3 criteria; Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan
At 5 years
Technical success
Time Frame: Periprocedural
As per VARC-3 criteria
Periprocedural
Device success
Time Frame: At 3 months
as per VARC-3 criteria
At 3 months
Early safety
Time Frame: At 3 months
As per VARC-3 criteria
At 3 months
Clinical efficacy
Time Frame: At 1 year
As per VARC-3 criteria
At 1 year
Valve-related long-term clinical efficacy
Time Frame: At 5 years
As per VARC-3 criteria; Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan
At 5 years
Freedom from mortality
Time Frame: Periprocedural, at 3 months and at 1 year
Freedom from mortality
Periprocedural, at 3 months and at 1 year
Risk of cardiovascular mortality
Time Frame: At 1 year
Risk of cardiovascular mortality. VARC-3 criteria
At 1 year
Risk of non-cardiovascular mortality
Time Frame: At 1 year
Risk of non-cardiovascular mortality. VARC-3 criteria
At 1 year
Risk of acute kidney injury
Time Frame: At 3 months
Risk of acute kidney injury stage 3 or 4. VARC-3 criteria
At 3 months
Risk of bleeding
Time Frame: At 3 months, 1 year and 5 years (Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan)
Risk of VARC-3 type 2-4 bleeding
At 3 months, 1 year and 5 years (Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan)
Risk of stroke
Time Frame: At 3 months and 1 year
Risk of all stroke
At 3 months and 1 year
Risk of thomboembolism
Time Frame: At 5 years
Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies). VARC-3 criteria.
At 5 years
Rate of successful access
Time Frame: Periprocedural
Successful access, delivery of the device, and retrieval of the delivery system
Periprocedural
Freedom from surgery or intervention
Time Frame: Periprocedural and at 3 months
Rate of freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Periprocedural and at 3 months
Risk of vascular complications
Time Frame: At 3 months
Risk of major vascular, access-related, or cardiac structural complication, VARC-3 criteria.
At 3 months
Risk of aortic prosthetic regurgitation
Time Frame: At 3 months
Freedom from moderate or severe aortic regurgitation. VARC-3 criteria
At 3 months
Risk of permanent pacemaker
Time Frame: At 3 months
Risk of new permanent pacemaker due to procedure-related conduction abnormalities
At 3 months
Risk of procedure or valve-related hospitalization
Time Frame: At 1 year
Risk of hospitalization for procedure- or valve-related causes. VARC-3
At 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ole De Backer

Investigators

  • Principal Investigator: Ole De Backer, MD, PhD, FESC, The Heart Center, Rigshospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2025

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2033

Study Registration Dates

First Submitted

June 8, 2025

First Submitted That Met QC Criteria

June 27, 2025

First Posted (Actual)

June 29, 2025

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OptEx-TAVI Trial
  • H-25039123 (Other Identifier: Scientific Ethics Committees for the Capital Region of Denmark)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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