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Impact of local tissue inflammation on intramyocardial conduction pathways post percutaneous valve : evaluation by positron emission tomography on exploratory cohort
EU CTIS ID: 2024-514587-44-00
What this study is testing
To study the association between the occurrence of conduction disorders after percutaneous aortic valve and the degree of inflammation of intramyocardial conduction pathways assessed by 18F-FDG PET-CT, based on observation of subjects in an exploratory cohort.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients over 18 years of age
- Patient with tight aortic stenosis defined by aortic valve area ≤ 1cm2 (or indexed aortic valve area ≤ 0.6 cm2/m2 body surface area), OR maximum transvalvular velocity ≥ 4 m/s OR mean transvalvular gradient ≥ 40 mmHg, assessed by transthoracic echocardiography (TTE) performed in a patient at rest
- Symptomatic patient with: dyspnea ≥ stage 2 according to New York Heart Association (NYHA) classification OR pathological stress test with onset of symptoms on exertion, drop in blood pressure or rhythm disturbance on exertion OR Asymptomatic with Left Ventricular Ejection Fraction (LVEF) < 50%
- Patient with vascular anatomy compatible with percutaneous femoral valve implantation
- Patient affiliated to or benefiting from a health insurance scheme
- Patient has provided free, informed and written consent
You likely can't join if
- Patients with pacemakers or triple-chamber defibrillators prior to TAVI (Transcatheter Aortic Valve Implantation) implantation
- Patient deprived of liberty by judicial or administrative decision, under guardianship or trusteeship
- Patient with life expectancy < 12 months
- Patients with a uni or bicuspid aortic valve
- Patients with severe left ventricular dysfunction (LVEF < 30%)
- Patients with other significant valvulopathies: aortic insufficiency ≥ grade 3, mitral insufficiency ≥ grade 3 or tight mitral stenosis
See the full eligibility criteria
- Patients over 18 years of age
- Patient with tight aortic stenosis defined by aortic valve area ≤ 1cm2 (or indexed aortic valve area ≤ 0.6 cm2/m2 body surface area), OR maximum transvalvular velocity ≥ 4 m/s OR mean transvalvular gradient ≥ 40 mmHg, assessed by transthoracic echocardiography (TTE) performed in a patient at rest
- Symptomatic patient with: dyspnea ≥ stage 2 according to New York Heart Association (NYHA) classification OR pathological stress test with onset of symptoms on exertion, drop in blood pressure or rhythm disturbance on exertion OR Asymptomatic with Left Ventricular Ejection Fraction (LVEF) < 50%
- Patient with vascular anatomy compatible with percutaneous femoral valve implantation
- Patient affiliated to or benefiting from a health insurance scheme
- Patient has provided free, informed and written consent
- Patients with pacemakers or triple-chamber defibrillators prior to TAVI (Transcatheter Aortic Valve Implantation) implantation
- Patient deprived of liberty by judicial or administrative decision, under guardianship or trusteeship
- Patient with life expectancy < 12 months
- Patients with a uni or bicuspid aortic valve
- Patients with severe left ventricular dysfunction (LVEF < 30%)
- Patients with other significant valvulopathies: aortic insufficiency ≥ grade 3, mitral insufficiency ≥ grade 3 or tight mitral stenosis
- Patient with iliofemoral vascular anatomy preventing safe passage of valve
- Patient with pre-existing TAVI bioprosthesis or mechanical prosthesis, in any position
- Inability or refusal to give consent
- Pregnant or breast-feeding woman
- Patients under court protection or family guardianship
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.