Aortic Valve StenosisPhase 2IMPACTNCT05308888
Impact of Local Tissue Inflammation on Intramyocardial Conduction Pathways Post Percutaneous Valve : Evaluation by Positron Emission Tomography on Exploratory Cohort
A Phase 2 study testing 18F-FDG PET-CT in people with Aortic Valve Stenosis, run by University Hospital, Brest at 1 site in France.
Trial summary
Aortic valve stenosis is the most common valve disease leading to surgical or percutaneous intervention in Europe and North America. Percutaneous aortic valve replacement (TAVI) is currently recommended for the management of patients with symptomatic aortic stenosis and with high; very high operative risk of aortic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- 18F-FDG PET-CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2022to 23 Nov 2028
- Phase
- Phase 2
- 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
- Major patient (>18 years of age);
- Patient with aortic stenosis defined by aortic valve area ≤ 1cm2 (or indexed aortic valve area ≤ 0.6 cm2/m2 body surface area), OR transvalvular peak velocity ≥ 4 m/s OR transvalvular mean gradient ≥ 40 mmHg, as assessed by transthoracic echocardiography performed in a patient at rest;
- Symptomatic patient with: dyspnea ≥ New-York Heart Association (NYHA) stage 2 OR pathological stress test with onset of symptoms on exertion, blood pressure drop, or rhythm disorder on exertion OR Asymptomatic with Left Ventricular Ejection Fraction < 50% ;
- Patient with vascular anatomy compatible with percutaneous femoral valve implantation;
- Patient affiliated to or benefiting from a health insurance plan;
- Patient who has provided free, informed and written consent.
Who cannot join
- Patient with a pacemaker or triple chamber defibrillator prior to TAVI implantation;
- Patient with a uni or bicuspid aortic valve;
- Patient with severe left ventricular dysfunction LVEF < 30%;
- Patient with other significant valve disease : aortic insufficiency ≥ grade 3, mitral insufficiency ≥ grade 3 or tight mitral stenosis ;
- Patient with iliofemoral vascular anatomy preventing safe passage of the valve;
- Patient with a pre-existing bioprosthesis or mechanical prosthesis at TAVI in any position;
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- Inability or refusal to consent;
- Pregnant or breastfeeding woman;
- Patient under judicial protection or family habilitation;
- Patient deprived of liberty by judicial or administrative decision, under guardianship or curatorship;
- Patient with life expectancy < 12 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Brest
Brest, 29609
Romain Didier, Dr, 298347392 ext. +33, romain.didier@chu-brest.fr
Romain Didier, Dr
About this study
Aortic valve stenosis is the most common valve disease leading to surgical or percutaneous intervention in Europe and North America. Percutaneous aortic valve replacement (TAVI) is currently recommended for the management of patients with symptomatic aortic stenosis and with high; very high operative risk of aortic valve replacement surgery or intermediate operative risk of aortic valve replacement surgery after a benefit-risk assessment by a heart team and operative contraindication to conventional aortic valve replacement surgery. These indications are supported by the 2017 European Cardiology guidelines.
This technique of percutaneous arterial valve implantation is most often performed via the femoral route, under local anesthesia, with placement of a prosthetic biological valve in the aortic position, impacting it into the patient's native aortic valve.
Read more
TAVI has been shown to be superior to medical treatment in patients with a aortic valve stenosis at very high operative risk of conventional aortic valve replacement surgery. However, the occurrence of atrioventricular conduction disorders (de novo left bundle branch block (LBBB) or complete AVB) remains the most frequent complication after TAVI. Therefore, the rate of pacemaker (PM) implantation after TAVI remains high, ranging from 2% to 51%, with an average rate of 13%.
Pacemaker implantation has several deleterious effects (increased hospitalization time, desynchronization of the left ventricle by permanent right ventricular pacing, exposure of the patient to procedural complications of pacemaker placement, and possible increase in the final cost to society of the initial hospitalization.
Not all patients who received a pacemaker post TAVI implantation use their PM. The rate of Pacemaker dependency and therefore of patients who actually use their pacemaker is approximately 33-36% at 1 year after percutaneous valve implantation.
In view of all the potentially deleterious consequences of post TAVI pacemaker implantation, it is therefore necessary to know which patients really justify pacemaker implantation after percutaneous valve implantation.
The purpose of this study is to investigate diagnostic imaging criteria that may be predictive of the occurrence of intramyocardial conduction disorders post TAVI implantation. Although some patients present only transient conductive disturbances, the impact of tissue inflammation of the intramyocardial conduction pathways after TAVI remains to be understood.
- Conditions
- Aortic Valve Stenosis
- Being tested
- 18F-FDG PET-CT
- Keywords
- TAVI
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET-CTDiagnostic test
The 18F-FDG PET-CT will be performed in the nuclear medicine department of the CHU of Brest. For this exam, the administration of 2-3 MBq/kg of 18F-FDG ([18F]F-fluorodeoxyglucose) will be performed to the patient in a single intravenous injection.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All patients will have to undergo an 18F-FDG PET-CT. Receives: Diagnostic Test: 18F-FDG PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a conductive disorder
The primary end point is "occurrence of conductive disturbance": 1) complete BAV, 2) high-grade BAV, 3) LBBB, 4) RBBB, 5) BAV1; assessed by the performance of post-percutaneous valve implantation electrocardiograms (ECGs) during the initial patient's hospitalization.
Measured: Up to 5 days after TAVI's implantation
Secondary outcomes (3)
Number of participants requiring pacemaker implantation
Number of participants requiring pacemaker implantation post-TAVI
Measured: Up to 5 days after TAVI's implantation, 1, 6 and 12 months
Simulation rate of pacemaker
Simulation rate of the right ventricular lead of the pacemaker at 1 and 6 months after TAVI's implantation
Measured: 1 and 6 month
Occurrence of a conductive disorder
Occurrence of a conductive disorder (atrioventricular blocks or high-grade atrioventricular block or left buncle branch block or right bundle branch block or atrioventricular block grade 1) within 6 months of discharge from TAVI's hospitalization.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start23 Nov 2022
- Primary completion23 Nov 2027 (estimated)
- Study completion23 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308888
- Sponsor's protocol ID
- 29BRC21.0255 (IMPACT)
- Acronym
- IMPACT
- Status last verified
- Jun 2026
- First submitted
- 15 Mar 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Local Tissue Inflammation on Intramyocardial Conduction Pathways Post Percutaneous Valve : Evaluation by Positron Emission Tomography on Exploratory Cohort
- ClinicalTrials.gov ID
- NCT05308888
- Acronym / sponsor ID
- IMPACT / 29BRC21.0255 (IMPACT)
- Conditions
- Aortic Valve Stenosis
- Keywords
- TAVI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 23 Nov 2027 (estimated)
- Study completion
- 23 Nov 2028 (estimated)
- First posted
- 4 Apr 2022 (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.
Aortic valve stenosis is the most common valve disease leading to surgical or percutaneous intervention in Europe and North America. Percutaneous aortic valve replacement (TAVI) is currently recommended for the management of patients with symptomatic aortic stenosis and with high; very high operative risk of aortic valve replacement surgery or intermediate operative risk of aortic valve replacement surgery after a benefit-risk assessment by a heart team and operative contraindication to conventional aortic valve replacement surgery. These indications are supported by the 2017 European Cardiology guidelines.
This technique of percutaneous arterial valve implantation is most often performed via the femoral route, under local anesthesia, with placement of a prosthetic biological valve in the aortic position, impacting it into the patient's native aortic valve.
TAVI has been shown to be superior to medical treatment in patients with a aortic valve stenosis at very high operative risk of conventional aortic valve replacement surgery. However, the occurrence of atrioventricular conduction disorders (de novo left bundle branch block (LBBB) or complete AVB) remains the most frequent complication after TAVI. Therefore, the rate of pacemaker (PM) implantation after TAVI remains high, ranging from 2% to 51%, with an average rate of 13%.
Pacemaker implantation has several deleterious effects (increased hospitalization time, desynchronization of the left ventricle by permanent right ventricular pacing, exposure of the patient to procedural complications of pacemaker placement, and possible increase in the final cost to society of the initial hospitalization.
Not all patients who received a pacemaker post TAVI implantation use their PM. The rate of Pacemaker dependency and therefore of patients who actually use their pacemaker is approximately 33-36% at 1 year after percutaneous valve implantation.
In view of all the potentially deleterious consequences of post TAVI pacemaker implantation, it is therefore necessary to know which patients really justify pacemaker implantation after percutaneous valve implantation.
The purpose of this study is to investigate diagnostic imaging criteria that may be predictive of the occurrence of intramyocardial conduction disorders post TAVI implantation. Although some patients present only transient conductive disturbances, the impact of tissue inflammation of the intramyocardial conduction pathways after TAVI remains to be understood.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: 18F-FDG PET-CTAll patients will have to undergo an 18F-FDG PET-CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Major patient (>18 years of age);
- Patient with aortic stenosis defined by aortic valve area ≤ 1cm2 (or indexed aortic valve area ≤ 0.6 cm2/m2 body surface area), OR transvalvular peak velocity ≥ 4 m/s OR transvalvular mean gradient ≥ 40 mmHg, as assessed by transthoracic echocardiography performed in a patient at rest;
- Symptomatic patient with: dyspnea ≥ New-York Heart Association (NYHA) stage 2 OR pathological stress test with onset of symptoms on exertion, blood pressure drop, or rhythm disorder on exertion OR Asymptomatic with Left Ventricular Ejection Fraction < 50% ;
- Patient with vascular anatomy compatible with percutaneous femoral valve implantation;
- Patient affiliated to or benefiting from a health insurance plan;
Key exclusion criteria (11 listed)
- Patient with a pacemaker or triple chamber defibrillator prior to TAVI implantation;
- Patient with a uni or bicuspid aortic valve;
- Patient with severe left ventricular dysfunction LVEF < 30%;
- Patient with other significant valve disease : aortic insufficiency ≥ grade 3, mitral insufficiency ≥ grade 3 or tight mitral stenosis ;
- Patient with iliofemoral vascular anatomy preventing safe passage of the valve;
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 |
|---|---|---|
| 18F-FDG PET-CTThe 18F-FDG PET-CT will be performed in the nuclear medicine department of the CHU of Brest. For this exam, the administration of 2-3 MBq/kg of 18F-FDG ([18F]F-fluorodeoxyglucose) will be performed to the patient in a single intravenous injection. | Diagnostic test | Intervention |
Primary outcome
Occurrence of a conductive disorder
Time frame: Up to 5 days after TAVI's implantation
The primary end point is "occurrence of conductive disturbance": 1) complete BAV, 2) high-grade BAV, 3) LBBB, 4) RBBB, 5) BAV1; assessed by the performance of post-percutaneous valve implantation electrocardiograms (ECGs) during the initial patient's hospitalization.
3 secondary outcomes
Number of participants requiring pacemaker implantation
Time frame: Up to 5 days after TAVI's implantation, 1, 6 and 12 months
Simulation rate of pacemaker
Time frame: 1 and 6 month
Occurrence of a conductive disorder
Time frame: 6 month
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 9 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-FDG PET-CT in people with Aortic Valve Stenosis, run by University Hospital, Brest at 1 site in France.
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 6 inclusion and 11 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 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Romain Didier, Dr (298347392 ext. +33, romain.didier@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a conductive disorder (time frame: Up to 5 days after TAVI's implantation). 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 9 Jun 2026.