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RECRUITING
NCT06833138
NA

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

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

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 The catheter will be advanced to the His Bundle and then slightly withdrawn proximally and caudally in order to target the compact atrioventricular node.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.

DEVICE

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