Aortic stenosis TAVI Cardiac conduction disorders Pacemaker MedDRA version: 20.0 Level: PT Classification code 10050559 Term: Aortic valve calcification System Organ Class: 10007541 - Cardiac disorders MedDRA version: 21.1 Level: PT Classification code 10077015 Term: Transcatheter aortic valve implantation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: FLUDESOXYGLUCOSE (18F)-CURIUM
Product Name: FLUDESOXYGLUCOSE (18F)-CURIUM
Product Code: FDG Scan ( 18F) 185 MBq/mL
Pharmaceutical Form: Injection
Sponsors
CHU de Brest
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - 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 guardianship or curatorship; - Patient with life expectancy < 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate the association between the occurrence of conduction disturbances after percutaneous aortic valve and the degree of inflammation of the intramyocardial conduction pathways assessed by PET scan.;Secondary Objective: The secondary objectives of the study are: - To investigate the association between the degree of intramyocardial conduction pathway inflammation assessed by PET scan and the need for pacemaker implantation after percutaneous aortic valve. - To identify predictive factors of pacemaker dependence at 1 and 6 months. ;Primary end point(s): The primary end point is "occurrence of conductive disturbance": 1) complete BAV, 2) high-grade BAV, 3) LBBB, 4) RBBB, 5) BAV1; assessed by the performance of post-percutaneous valve implantation electrocardiograms (ECGs) during the initial patient's hospitalization.;Timepoint(s) of evaluation of this end point: During the initial patient's hospitalization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Post-TAVI pacemaker implantation - Post-TAVI PM dependence at 1 month, 6 months (binary criterion of dependence and simulation rate) - "Occurrence of a conductive disorder" within 6 months of discharge from TAVI's hospitalization. ;Timepoint(s) of evaluation of this end point: During the initial patient's hospitalization, 1 month, and 6 months postpercutaneous valve implantation. | — |
Countries
France
Contacts
Public ContactMenez
CHU de Brest
Outcome results
None listed