Status:
UNKNOWN
Impact of Local Tissue Inflammation on Intramyocardial Conduction Pathways Post Percutaneous Valve : Evaluation by Positron Emission Tomography on Exploratory Cohort
Lead Sponsor:
University Hospital, Brest
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 recommend...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05308888
Start Date
May 1 2022
End Date
May 1 2024
Last Update
April 4 2022
Active Locations (1)
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1
CHU de Brest
Brest, France, 29609