FLUDEOXYGLUCOSE (18F) for Aortic stenosis

Inclusion criteria

• {"criterion_text":"- Patients over 18 years of age"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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%"}
• {"criterion_text":"- Patient with vascular anatomy compatible with percutaneous femoral valve implantation"}
• {"criterion_text":"- Patient affiliated to or benefiting from a health insurance scheme"}
• {"criterion_text":"- Patient has provided free, informed and written consent"}

Exclusion criteria

• {"criterion_text":"- Patients with pacemakers or triple-chamber defibrillators prior to TAVI (Transcatheter Aortic Valve Implantation) implantation"}
• {"criterion_text":"- Patient deprived of liberty by judicial or administrative decision, under guardianship or trusteeship"}
• {"criterion_text":"- Patient with life expectancy < 12 months"}
• {"criterion_text":"- Patients with a uni or bicuspid aortic valve"}
• {"criterion_text":"- Patients with severe left ventricular dysfunction (LVEF < 30%)"}
• {"criterion_text":"- Patients with other significant valvulopathies: aortic insufficiency ≥ grade 3, mitral insufficiency ≥ grade 3 or tight mitral stenosis"}
• {"criterion_text":"- Patient with iliofemoral vascular anatomy preventing safe passage of valve"}
• {"criterion_text":"- Patient with pre-existing TAVI bioprosthesis or mechanical prosthesis, in any position"}
• {"criterion_text":"- Inability or refusal to give consent"}
• {"criterion_text":"- Pregnant or breast-feeding woman"}
• {"criterion_text":"- Patients under court protection or family guardianship"}

Primary endpoints

• {"endpoint_text":"- Intra-hospital \"occurrence of a conductive disorder\", a composite criterion comprising: 1) complete AVB, 2) high-grade AVB, 3) LBB, 4) RBB, 5) AVB1; assessed by electrocardiograms (ECG post percutaneous valve implantation) performed during the initial hospitalization","definition_or_measurement_approach":"Composite of listed conduction disorders assessed by ECGs performed during the initial hospitalization after percutaneous valve implantation"}

Secondary endpoints

• {"endpoint_text":"- Post-TAVI pacemaker implantation","definition_or_measurement_approach":"Occurrence of pacemaker implantation after TAVI (event recorded)"}
• {"endpoint_text":"- Post-TAVI pacemaker dependence at 1 month, 6 months","definition_or_measurement_approach":"Assessment of pacemaker dependence at 1 month and 6 months post-TAVI"}
• {"endpoint_text":"- \"Occurrence of a conductive disorder\" within 6 months of discharge from TAVI hospitalization","definition_or_measurement_approach":"Occurrence of the composite conductive disorder (as defined in primary endpoint) assessed within 6 months after discharge"}

France

Earliest CTIS Part Ii Submission Date

07-06-2024

Latest Decision Or Authorization Date

07-11-2025

Processing Time Days

518

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Centre Hospitalier Regional Et Universitaire De Brest

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France