Impact of local tissue inflammation on intramyocardial conduction pathways post percutaneous valve : evaluation by positron emission tomography on exploratory cohort

Phase 1

Conditions: Aortic stenosis
MedDRA version: 20.1Level: PTClassification code: 10002906Term: Aortic stenosis Class: 100000004866
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: CTIS2024-514587-44-00

Lead Sponsor: Centre Hospitalier Regional Et Universitaire De Brest

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion 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

Exclusion Criteria

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