CTIS2024-514587-44-00Active, not recruitingPhase 1
Impact of local tissue inflammation on intramyocardial conduction pathways post percutaneous valve : evaluation by positron emission tomography on exploratory cohort - 29BRC21.0255
Centre Hospitalier Regional Et Universitaire De Brest0 sites100 target enrollmentStarted: May 27, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
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
Investigators
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