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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

NCT06833138 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

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 The catheter will be advanced to the His Bundle and then slightly withdrawn proximally and caudally in order to target the compact atrioventricular node.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

Sponsors & Collaborators

  • Medtronic France SAS

    collaborator INDUSTRY

  • ClinSearch

    collaborator OTHER

  • French Cardiology Society

    lead OTHER

Principal Investigators

  • Frédéric ANSELME, MD · CHU de Rouen, France

  • Corentin CHAUMONT, MD · CHU de Rouen, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2029-05-31
Completion
2029-12-31

Countries

  • Belgium
  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06833138 on ClinicalTrials.gov