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Atrioventricular Node Ablation and Conduction System Pacing in Patients With Well Controlled Permanent Atrial Fibrillation (AF), Heart Failure and Preserved Ejection Fraction: Heart Rate Regularization Versus Medical Rate Control
Sponsor: French Cardiology Society
Summary
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.
Official title: Atrioventricular (AV) Node Ablation and Conduction System Pacing in Patients With Well Controlled Permanent Atrial Fibrillation (AF), Heart Failure and Preserved Ejection Fraction: Heart Rate Regularization vs. Medical Rate Control
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
266
Start Date
2025-09-10
Completion Date
2029-12-31
Last Updated
2025-09-22
Healthy Volunteers
No
Interventions
pacemaker implantation
The 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
Right-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 The catheter will be advanced to the His Bundle and then slightly withdrawn proximally and caudally in order to target the compact atrioventricular node.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
The pacemaker device will be programmed in VVIR mode at a lower rate of 75 beats per minute in bipolar mode for sensing and pacing
Locations (15)
OLV Aalst
Aalst, Belgium
UZ Leuven
Leuven, Belgium
Clinique St Pierre Ottignies
Ottignies-Louvain-la-Neuve, Belgium
CHRU de Brest - Hôpital de la Cavale Blanche
Brest, France
CHRU de Caen
Caen, France
CHRU de Tours - Trousseau
Chambray-lès-Tours, France
CHU Grenoble Alpes
Grenoble, France
Groupe Hospitalier La Rochelle-Ré-Aunis
La Rochelle, France
CHRU Lille
Lille, France
GHICL Allome - Hôpital St Philibert
Lomme, France
Clinique Millenaire
Montpellier, France
CHU de Nantes - Hôpital Nord Laennec
Nantes, France
CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévèque
Pessac, France
CHU Poitiers
Poitiers, France
CHU de Rouen
Rouen, France