Aortic Stenosis DiseaseOptEx-TAVINCT07042529
Optimized Expansion of the Implanted Transcatheter Aortic Valve
A study testing OptEx-TAVI and SoC-TAVI in people with Aortic Stenosis Disease and Valvular Heart Disease, run by Ole De Backer at 17 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis Disease, Valvular Heart Disease
- What is being tested?
- OptEx-TAVI and SoC-TAVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 17 sitesin 6 countries
- Study dates
- 5 Oct 2025to 1 Jul 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe native aortic valve stenosis
- Indication for TAVI
- Ability to understand and to comply with the study protocol
Who cannot join
- 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 locations and contacts
17 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 6 countries
Belgium4 sites, 4 recruiting
- Recruiting
AZORG ziekenhuis
Aalst
Liesbeth Rosseel, MD, PhD, +32 53 72 41 11, Liesbeth.rosseel@azorg.be
- Recruiting
CHU Charleroi
Charleroi, 6000
Adel Aminian, adel.aminian@chu-charleroi.be
- Recruiting
UZ Leuven
Leuven, 3000
Christophe Dubois, MD, PhD, christophe.dubois@uzleuven.be
- Recruiting
AZ Delta
Roeselare
Maarten Vanhaverbeke, MD, PhD, +32 51 23 61 11, Maarten.Vanhaverbeke@azdelta.be
Denmark4 sites, 4 recruiting
- Not yet recruiting
Skejby Hospital
Aa, 8200
Christian J Terkelsen, christian.juhl.terkelsen@clin.au.dk
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Ashkan Eftekhari, asef@rn.dk
- Recruiting
Rigshospitalet
Copenhagen
Ole De Backer, MD, PhD, FESC, +4535457086, ole.de.backer@regionh.dk
Troels H Jørgensen, MD, PhD, +4535450892, troels.hoejsgaard.joergensen.01@regionh.dk
- Not yet recruiting
Odense University Hospital
Odense C, 5000
Henrik Nissen, henrik.nissen@rsyd.dk
Netherlands4 sites, 4 recruiting
- Recruiting
UMC Amsterdam
Amsterdam
Ronak Delewi, MD, (020) 444 4444, r.delewi@amsterdamumc.nl
- Recruiting
University Medical Center Groningen
Groningen
Joanna J Wykrzykowska, MD, PhD, +31 50 361 6161, j.j.wykrzykowska@umcg.nl
- Recruiting
Leiden University Medical Center
Leiden
Frank van der Kley, +31 71 526 9111, F.van_der_kley@lumc.nl
- Recruiting
St. Antonius Hospital
Nieuwegein, 3435
Jur ten Berg, MD, PhD, j.ten.berg@antoniusziekenhuis.nl
Christian Overduin, MD, PhD, c.overduin@antoniusziekenhuis.nl
Norway2 sites, 2 recruiting
- Recruiting
Haukeland hospital
Haukeland
Erik Packer, MD, +47 55 97 50 00, erik.packer@helse-bergen.no
- Recruiting
Oslo universitetssygehus
Oslo, 0450
Kristoffer Engh Russell, MD, PhD, krruss@ous-hf.no
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 413 45
Oskar Angerås, MD, PhD, oskar.angeras@vgregion.se
- Recruiting
Skånes universitetssjukhus
Skåne
Helle Søholm, MD, PhD, +46 46 17 10 00, helle.soholm@gmail.com
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, 20520
Mikko Savontaus, mikko.savontaus@tyks.fi
About this study
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
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.
Read the 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
- Conditions
- Aortic Stenosis Disease, Valvular Heart Disease
- Being tested
- OptEx-TAVI, SoC-TAVI
- Keywords
- Aortic stenosis, Cardiovascular, Transcatheter aortic valve, Transcatheter aortic valve implantation, Valvular heart disease, TAVI
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptEx-TAVIProcedure or surgery
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-TAVIProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| SoC-TAVI | Active comparator | 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. Receives: Procedure: SoC-TAVI |
| OptEx-TAVI | Experimental | Systematic pre-dilatation and post-dilatation with an optimally-sized balloon Receives: Procedure: OptEx-TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
At least one TAV leaflet with HALT
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 .
Measured: At three months after TAVI
Secondary outcomes (26)
HALT 50%
At least one TAV leaflet with HALT involving ≥ 50% of the leaflet curvilinear dimension assessed by cardiac CT-scan
Measured: At 3 months/At 1 year
HALT 25%
The rate of TAV leaflets with HALT involving ≥ 25% of the leaflet curvilinear dimension assessed by cardiac CT-scan
Measured: At 3 months/At 1 year
HALT 50%, multiple
The rate of TAV leaflets with HALT involving ≥ 50% of the leaflet curvilinear dimension assessed by cardiac CT-scan
Measured: At 3 months/At 1 year
Bioprosthetic leaflet micro-calcification target-to-background ratio
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
Measured: At 5 years
Valve performance
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
Measured: At 3 months/At 1 year
structural valve deterioration
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
Measured: At 5 years
Bioprosthetic valve dysfunction (BVD)
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
Measured: At 5 years
Bioprosthetic valve failure (BVF)
As per VARC-3 criteria; Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan
Measured: At 5 years
Technical success
As per VARC-3 criteria
Measured: Periprocedural
Device success
as per VARC-3 criteria
Measured: At 3 months
Early safety
As per VARC-3 criteria
Measured: At 3 months
Clinical efficacy
As per VARC-3 criteria
Measured: At 1 year
Valve-related long-term clinical efficacy
As per VARC-3 criteria; Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan
Measured: At 5 years
Freedom from mortality
Freedom from mortality
Measured: Periprocedural, at 3 months and at 1 year
Risk of cardiovascular mortality
Risk of cardiovascular mortality. VARC-3 criteria
Measured: At 1 year
Risk of non-cardiovascular mortality
Risk of non-cardiovascular mortality. VARC-3 criteria
Measured: At 1 year
Risk of acute kidney injury
Risk of acute kidney injury stage 3 or 4. VARC-3 criteria
Measured: At 3 months
Risk of bleeding
Risk of VARC-3 type 2-4 bleeding
Measured: 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
Risk of all stroke
Measured: At 3 months and 1 year
Risk of thomboembolism
Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies). VARC-3 criteria.
Measured: At 5 years
Rate of successful access
Successful access, delivery of the device, and retrieval of the delivery system
Measured: Periprocedural
Freedom from surgery or intervention
Rate of freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Measured: Periprocedural and at 3 months
Risk of vascular complications
Risk of major vascular, access-related, or cardiac structural complication, VARC-3 criteria.
Measured: At 3 months
Risk of aortic prosthetic regurgitation
Freedom from moderate or severe aortic regurgitation. VARC-3 criteria
Measured: At 3 months
Risk of permanent pacemaker
Risk of new permanent pacemaker due to procedure-related conduction abnormalities
Measured: At 3 months
Risk of procedure or valve-related hospitalization
Risk of hospitalization for procedure- or valve-related causes. VARC-3
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start5 Oct 2025
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,010 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ole De Backer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ole De Backer, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ole De Backer, MD, PhD, FESC, Principal investigator, The Heart Center, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042529
- Sponsor's protocol ID
- OptEx-TAVI Trial
- Other IDs
- H-25039123
- Acronym
- OptEx-TAVI
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07042529
- Acronym / sponsor ID
- OptEx-TAVI / OptEx-TAVI Trial
- Conditions
- Aortic Stenosis Disease, Valvular Heart Disease
- Keywords
- Aortic stenosis, Cardiovascular, Transcatheter aortic valve, Transcatheter aortic valve implantation, Valvular heart disease, TAVI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,010 participants (estimated)
- Lead sponsor
- Ole De BackerUniversity, hospital or other
- Study start
- 5 Oct 2025 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2033 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SoC-TAVI | Active comparator | Procedure: SoC-TAVIPre-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. |
| OptEx-TAVI | Experimental | Procedure: OptEx-TAVISystematic pre-dilatation and post-dilatation with an optimally-sized balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe native aortic valve stenosis
- Indication for TAVI
- Ability to understand and to comply with the study protocol
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptEx-TAVIDuring 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. | Procedure or surgery | OptEx-TAVI |
| SoC-TAVIDuring 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. | Procedure or surgery | SoC-TAVI |
Primary outcome
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 .
26 secondary outcomes
HALT 50%
Time frame: At 3 months/At 1 year
HALT 25%
Time frame: At 3 months/At 1 year
HALT 50%, multiple
Time frame: At 3 months/At 1 year
Bioprosthetic leaflet micro-calcification target-to-background ratio
Time frame: At 5 years
Valve performance
Time frame: At 3 months/At 1 year
structural valve deterioration
Time frame: At 5 years
Bioprosthetic valve dysfunction (BVD)
Time frame: At 5 years
Bioprosthetic valve failure (BVF)
Time frame: At 5 years
Technical success
Time frame: Periprocedural
Device success
Time frame: At 3 months
Early safety
Time frame: At 3 months
Clinical efficacy
Time frame: At 1 year
Valve-related long-term clinical efficacy
Time frame: At 5 years
Freedom from mortality
Time frame: Periprocedural, at 3 months and at 1 year
Risk of cardiovascular mortality
Time frame: At 1 year
Risk of non-cardiovascular mortality
Time frame: At 1 year
Risk of acute kidney injury
Time frame: 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 stroke
Time frame: At 3 months and 1 year
Risk of thomboembolism
Time frame: At 5 years
Rate of successful access
Time frame: Periprocedural
Freedom from surgery or intervention
Time frame: Periprocedural and at 3 months
Risk of vascular complications
Time frame: At 3 months
Risk of aortic prosthetic regurgitation
Time frame: At 3 months
Risk of permanent pacemaker
Time frame: At 3 months
Risk of procedure or valve-related hospitalization
Time frame: At 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ole De Backer, MD, PhD, FESC principal investigator
The Heart Center, Rigshospitalet
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OptEx-TAVI and SoC-TAVI in people with Aortic Stenosis Disease and Valvular Heart Disease, run by Ole De Backer at 17 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Belgium, Denmark, Netherlands, Norway, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ole De Backer, MD, PhD, FESC (+4535457086, ole.de.backer@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At least one TAV leaflet with HALT (time frame: At three months after TAVI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.