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NCT Number: NCT07042529

Optimized Expansion of the Implanted Transcatheter Aortic Valve

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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Key information

Conditions

Aortic Stenosis Disease Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Valvular Heart Disease Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZORG ziekenhuis, Aalst, Belgium

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • 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.
  • 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.
  • Also, a balloon-expandable TAV has to be post-dilated with an optimally-sized balloon in case of randomization to the OptEx-TAVI arm.

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.

Primary outcomes

  1. 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 .

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Technical success

    Time frame: Periprocedural

    As per VARC-3 criteria

  10. Device success

    Time frame: At 3 months

    as per VARC-3 criteria

  11. Early safety

    Time frame: At 3 months

    As per VARC-3 criteria

  12. Clinical efficacy

    Time frame: At 1 year

    As per VARC-3 criteria

  13. 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

  14. Freedom from mortality

    Time frame: Periprocedural, at 3 months and at 1 year

    Freedom from mortality

  15. Risk of cardiovascular mortality

    Time frame: At 1 year

    Risk of cardiovascular mortality. VARC-3 criteria

  16. Risk of non-cardiovascular mortality

    Time frame: At 1 year

    Risk of non-cardiovascular mortality. VARC-3 criteria

  17. Risk of acute kidney injury

    Time frame: At 3 months

    Risk of acute kidney injury stage 3 or 4. VARC-3 criteria

  18. 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

  19. Risk of stroke

    Time frame: At 3 months and 1 year

    Risk of all stroke

  20. 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.

  21. Rate of successful access

    Time frame: Periprocedural

    Successful access, delivery of the device, and retrieval of the delivery system

  22. 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

  23. Risk of vascular complications

    Time frame: At 3 months

    Risk of major vascular, access-related, or cardiac structural complication, VARC-3 criteria.

  24. Risk of aortic prosthetic regurgitation

    Time frame: At 3 months

    Freedom from moderate or severe aortic regurgitation. VARC-3 criteria

  25. Risk of permanent pacemaker

    Time frame: At 3 months

    Risk of new permanent pacemaker due to procedure-related conduction abnormalities

  26. Risk of procedure or valve-related hospitalization

    Time frame: At 1 year

    Risk of hospitalization for procedure- or valve-related causes. VARC-3

Study contacts

Contact information is provided by the study sponsor or research team.

Ole De Backer, MD, PhD, FESC

CONTACT

[email protected]

+4535457086

Troels H Jørgensen, MD, PhD

CONTACT

[email protected]

+4535450892

Sponsors and collaborators

Lead sponsor

Ole De Backer

Other

Registry information

Official study 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

Acronym: OptEx-TAVI

Important dates

Study start
2025
Primary completion
2029
Study completion
2033
First posted
Jun 29, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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