NCT06833138Recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 266 (estimated)
- First submitted
- 13 Feb 2025
- Start date
- 10 Sept 2025
- Primary completion date
- 31 May 2029
- Lead sponsor
- French Cardiology Society
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT06833138
What you commit to
- Study type: Interventional
- Planned participants: 266
- From 10 Sept 2025 to the primary completion date, 31 May 2029
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous implanted devices (Pacemaker / Implantable Cardioverter-Defibrillator / Cardiac Resynchronization Therapy)
Other illness
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Besançon - Hôpital Jean Monjoz Coordinator of this site? Confirm its status | Besançon | France | Not yet recruiting |
| CHRU de Caen - Hôpital Côte de Nacre Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| CHRU de Tours - Hôpital Trousseau Coordinator of this site? Confirm its status | Chambray-lès-Tours | France | Recruiting |
| CHU de Clermont-Ferrand Hôpital Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Not yet recruiting |
| CHU Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble | France | Not yet recruiting |
| Groupe Hospitalier La Rochelle-Ré-Aunis Coordinator of this site? Confirm its status | La Rochelle | France | Recruiting |
| CHU de Lille - Institut Cœur-Poumons Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| GHICL Allome - Hôpital St Philibert Coordinator of this site? Confirm its status | Lomme | France | Recruiting |
| Clinique Millenaire Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU de Nantes - Hopital Nord Laennec Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| Institut Montsouris Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévèque Coordinator of this site? Confirm its status | Pessac | France | Not yet recruiting |
| CHU de Poitiers - Centre Cardiovasculaire Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| CHU de Rennes - Hôpital Pontchallou Coordinator of this site? Confirm its status | Rennes | France | Not yet recruiting |
| CHU de Rouen - Hôpital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Institut Arnault Tzanck Coordinator of this site? Confirm its status | Saint-Laurent-du-Var | France | Not yet recruiting |
| CHRU de Nancy - Hopitaux de Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.