Heart Rhythm Procedure Tested in People With Heart Failure and Permanent Atrial Fibrillation
Tests a pacemaker with heart node ablation in adults with heart failure and atrial fibrillation.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Besançon, Caen, Chambray-lès-Tours, Clermont-Ferrand, Grenoble, La Rochelle, Lille, Lomme, Montpellier, Nantes, Paris, Pessac, Poitiers, Rennes, Rouen, Saint-Laurent-du-Var, and Vandœuvre-lès-Nancy, FranceSee the 17 sites
Where in France
- CHU de Besançon - Hôpital Jean MonjozBesançon, FranceNot yet recruiting
- CHRU de Caen - Hôpital Côte de NacreCaen, FranceTaking people
- CHRU de Tours - Hôpital TrousseauChambray-lès-Tours, FranceTaking people
- CHU de Clermont-Ferrand Hôpital Gabriel MontpiedClermont-Ferrand, FranceNot yet recruiting
- CHU Grenoble AlpesGrenoble, FranceNot yet recruiting
- Groupe Hospitalier La Rochelle-Ré-AunisLa Rochelle, FranceTaking people
- CHU de Lille - Institut Cœur-PoumonsLille, FranceNot yet recruiting
- GHICL Allome - Hôpital St PhilibertLomme, FranceTaking people
- Clinique MillenaireMontpellier, FranceTaking people
- CHU de Nantes - Hopital Nord LaennecNantes, FranceNot yet recruiting
- Institut MontsourisParis, FranceNot yet recruiting
- CHU de Bordeaux - Hôpital Cardiologique du Haut-LévèquePessac, FranceNot yet recruiting
- CHU de Poitiers - Centre CardiovasculairePoitiers, FranceTaking people
- CHU de Rennes - Hôpital PontchallouRennes, FranceNot yet recruiting
- CHU de Rouen - Hôpital Charles NicolleRouen, FranceTaking people
- Institut Arnault TzanckSaint-Laurent-du-Var, FranceNot yet recruiting
- CHRU de Nancy - Hopitaux de BraboisVandœuvre-lès-Nancy, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- French Cardiology Society
- Trial code
- NCT06833138
- Record updated
- 11 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Previous implanted devices (Pacemaker / Implantable Cardioverter-Defibrillator / Cardiac Resynchronization Therapy); 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); Confirmed or suspected infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others); Patient eligible for atrial fibrilation catheter ablation; Life expectancy < 12 months; Class III obesity (Body Mass Index ≥ 40); Obstructive hypertrophic cardiomyopathy; Other indication for pacemaker implantation; Indication for implantable cardioverter-defibrillator; Ambulatory ≤ 50% of time; Pregnant women; Breast-feeding women.