Atrial Fibrillation Rapid
Conditions
Brief summary
The objective of the study is to evaluate the functional benefit of left bundle branch of His pacing compared to right ventricular pacing in patients implanted with a pacemaker prior to a atrioventricular node ablation procedure for rapid atrial fibrillation
Interventions
PROCEDUREleft bundle branch of His pacing
left bundle branch of His pacing
PROCEDUREright ventricular pacing
right ventricular pacing
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1/ Pacemaker implanted patient with LBTP lead and back-up right ventricular lead who subsequently underwent successful atrioventricular node ablation for rapid AF 2) NAV ablation procedure performed less than 15 days ago 3) Age ≥ 18 years 4) Woman of childbearing age with effective contraception (estrogen-progestin or intrauterine device or tubal ligation) for at least 1 month and for the duration of the study, and a negative urine pregnancy test by B-HCG at inclusion Or, Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit). 5\) Membership of a social security scheme 6) Patient follow-up feasible 7) Patient has read and understood the information leaflet and signed the informed consent form
Exclusion criteria
1. Impairment of autonomy such that a maximal cardiorespiratory effort test (VO2 Max test) cannot be performed under good conditions (ADL scale \< 5). 2. LVEF \< 40% at inclusion 3. Person deprived of liberty by an administrative or judicial decision, or person under court protection, sub-guardianship or curatorship. 4. Patient participating in another interventional trial 5. Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or from giving informed consent. 6. Pregnant, parturient or breast-feeding women, or those without proven contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Oxygen Consumption (VO2 max) in mL/min/kg. | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| walking test distance covered | 18 months |
| echography criteria: LVEF (%), indexed left ventricular end-systolic volume (mL/m2), indexed cardiac output (L/min/m2), inter-ventricular asynchrony criteria (aortic pre-ejection time - pulmonary pre-ejection time) | 18 months |
| Determination of NT pro BNP or BNP | 18 months |
| Physical component of quality-of-life scale (SF-36) | 18 months |
| Medico-economic criteria: incremental cost-utility ratio of LBTP versus RVP | 18 months |
Countries
France
Contacts
CONTACTCorentin CHAUMONT, MD
CONTACTArmelle GUIDOTTI
PRINCIPAL_INVESTIGATORCorentin CHAUMONT, MD
University Hospital, Rouen
Outcome results
None listed