The goal of this clinical trial is to assess the clinical efficacy of physiological pacing combined with atrioventricular node ablation, in patients with Heart Failure with preserved Ejection Fraction (HFpEF) and well controlled permanent atrial fibrillation.The main question it aims to answer is that heart rate regularization added to physiological pacing - preventing the deleterious effect of right ventricular apical pacing - would reduce mortality and heart failure hospitalizations.
Researchers will compare physiological pacing combined with atrioventricular node ablation (intervention arm) versus optimal pharmacological therapy (control arm) to see if physiological pacing combined with atrioventricular node ablation reduce time to the composite of all-cause mortality or hospitalization due to heart failure or intravenous diuretics (time frame 24 months).
Participants will :
* Be randomized in intervention arm or control arm. * Visit the clinic 3 months, 12 months and 24 months after the randomization for checkups and tests.
Permanent atrial fibrilation > 6 months
Preserved Left Ventricular Ejection Fraction ≥ 50%
≥ 1 heart failure hospitalization in the previous year
NYHA (New York Heart Association) score ≥ 2
Patient eligible for atrial fibrilation catheter ablation
Life expectancy < 12 months
Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml/1,73 m2)
Severe respiratory disease (severe chronic obstructive pulmonary disease with Gold ≥ 3 and/or chronic oxygen therapy)
Parallel
pacemaker implantation
Procedure/SurgeryThe Medtronic 3830 lead should be used as the Conduction System Pacing lead. However, in case of unsuccessful implantation with the 3830 lead, a stylet-driven lead can be used as an alternative.
atrioventricular node ablation
Procedure/SurgeryRight-sided atrioventricular junction ablation will be attempted first with a radiofrequency catheter. The choice of the catheter will be at the discretion of the physician. The catheter will be advanced to the His Bundle and then slightly withdrawn proximally and caudally in order to target the compact atrioventricular node. Repeated ablation procedures will be recommended during follow-up if regression of atrioventricular block occurs.
Pacemaker programming
DeviceThe pacemaker device will be programmed in VVIR mode at a lower rate of 75 beats per minute in bipolar mode for sensing and pacing
Time to the composite of all-cause mortality or hospitalization due to heart failure or intravenous diuretics.
Delay between randomization and death or hospitalization or intravenous diuretics due to heart failure
Time to all-cause mortality
Delay between randomization and death (all-cause).
Time to Cardiovascular mortality
Delay between randomization and death due to cardiovascular disease.
Time to heart failure hospitalization
Delay between randomization and hospitalization due to heart failure.
Change in New York Heart Association score
Evolution of the functional status measured by New York Heart Association score between randomization and 24 months follow up visit. From II (mild), III (moderate) to IV (severe).
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French Cardiology Society
Lead sponsor
Medtronic France SAS
Collaborator
