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Clinical Trials in France / NCT06833138
Recruiting Not applicable

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 · tracked via the Priya Life Science France tracker
Sponsor
French Cardiology Society
Phase
Not applicable
Started
2025-09-10
Last updated
2026-09-11

Condition(s) studied

Heart Failure With Preserved Ejection FractionAtrial Fibrillation, Persistent

Investigational drug(s) / intervention(s)

pacemaker implantationatrioventricular node ablationPacemaker programming

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 The catheter will be advanced to the His Bundle and then slightly withdrawn proximally and caudally in order to target the compact atrioventricular node.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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 * Presence of at least one of the following criteria related to diastolic dysfunction: * E/e' ratio \> 9 * Left Ventricular mass \> 95 g/m2 (female) or \> 115 g/m2 (male) with h/R ratio \> 0.42 * NT pro BNP (B-type Natriuretic Peptide) \> 365 pg/mL or BNP (B-type Natriuretic Peptide) \> 105 pg/mL * Narrow QRS ≤ 120 ms * Average heart rate ≤ 110/min on 24 hours Holter monitoring * Age over 18-year-old * Capacity to understand the nature of the study, legal ability and willingness to give informed consent * Patient covered by a social insurance * Effective contraception and a negative pregnancy test in women of a childbearing age Exclusion Criteria: * 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) * Class III obesity (Body Mass Index ≥ 40) * Confirmed or suspected infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others) * Obstructive hypertrophic cardiomyopathy * Previous implanted devices (Pacemaker / Implantable Cardioverter-Defibrillator / Cardiac Resynchronization Therapy) * Other indication for pacemaker implantation * Indication for implantable cardioverter-defibrillator * Ambulatory ≤ 50% of time * Pregnant women * Breast-feeding women

Primary outcome measure(s)

  • Time to the composite of all-cause mortality or hospitalization due to heart failure or intravenous diuretics. — 24 months
    Delay between randomization and death or hospitalization or intravenous diuretics due to heart failure

Trial sites (17)

FacilityCityRegionStatus
CHU de Besançon - Hôpital Jean Monjoz Besançon France Not Yet Recruiting
CHRU de Caen - Hôpital Côte de Nacre Caen France Recruiting
CHRU de Tours - Hôpital Trousseau Chambray-lès-Tours France Recruiting
CHU de Clermont-Ferrand - Hôpital Gabriel Montpied Clermont-Ferrand France Not Yet Recruiting
CHU Grenoble Alpes Grenoble France Not Yet Recruiting
Groupe Hospitalier La Rochelle-Ré-Aunis La Rochelle France Recruiting
CHU de Lille - Institut Cœur-Poumons Lille France Not Yet Recruiting
GHICL Allome - Hôpital St Philibert Lomme France Recruiting
Clinique Millenaire Montpellier France Recruiting
CHU de Nantes - Hôpital Nord Laennec Nantes France Not Yet Recruiting
Institut Montsouris Paris France Not Yet Recruiting
CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévèque Pessac France Not Yet Recruiting
CHU de Poitiers - Centre Cardiovasculaire Poitiers France Recruiting
CHU de Rennes - Hôpital Pontchallou Rennes France Not Yet Recruiting
CHU de Rouen - Hôpital Charles Nicolle Rouen France Recruiting
Institut Arnault Tzanck Saint-Laurent-du-Var France Not Yet Recruiting
CHRU de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy France Not Yet Recruiting

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Other trials for the same condition

Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity Recruiting
Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure Recruiting
PBMC as Biomarkers of Diabetic Cardiomyopathy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06833138 on ClinicalTrials.gov ↗ ← All trials in France