RecruitingNot ApplicableNCT06833138

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

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


Sponsor

French Cardiology Society

Enrollment

266 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two approaches to managing a slow, irregular heartbeat in patients with permanent atrial fibrillation (AF) and heart failure with preserved pump function: one approach uses a procedure to ablate the heart's electrical relay node and implant a pacemaker (conduction system pacing), and the other continues with medications alone to control heart rate. The goal is to see which approach better prevents hospitalizations and improves quality of life. **You may be eligible if...** - You have had permanent atrial fibrillation for more than 6 months - Your heart's pumping function is preserved (ejection fraction at least 50%) - You have been hospitalized at least once in the past year for heart failure - Your heart failure symptoms are moderate (NYHA class 2 or higher) - You have evidence of diastolic heart dysfunction (stiff heart) based on tests - Your heart rate is controlled (average 110 beats/min or lower on a 24-hour monitor) **You may NOT be eligible if...** - You have a wide QRS complex on your ECG - You have structural heart disease beyond what is defined in the study - You are under 18 or lack the legal capacity to consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREpacemaker 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.

PROCEDUREatrioventricular 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.

DEVICEPacemaker 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

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NCT06833138


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