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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
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

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Besançon - Hôpital Jean Monjoz
Coordinator of this site? Confirm its status
BesançonFranceNot yet recruiting
CHRU de Caen - Hôpital Côte de Nacre
Coordinator of this site? Confirm its status
CaenFranceRecruiting
CHRU de Tours - Hôpital Trousseau
Coordinator of this site? Confirm its status
Chambray-lès-ToursFranceRecruiting
CHU de Clermont-Ferrand Hôpital Gabriel Montpied
Coordinator of this site? Confirm its status
Clermont-FerrandFranceNot yet recruiting
CHU Grenoble Alpes
Coordinator of this site? Confirm its status
GrenobleFranceNot yet recruiting
Groupe Hospitalier La Rochelle-Ré-Aunis
Coordinator of this site? Confirm its status
La RochelleFranceRecruiting
CHU de Lille - Institut Cœur-Poumons
Coordinator of this site? Confirm its status
LilleFranceNot yet recruiting
GHICL Allome - Hôpital St Philibert
Coordinator of this site? Confirm its status
LommeFranceRecruiting
Clinique Millenaire
Coordinator of this site? Confirm its status
MontpellierFranceRecruiting
CHU de Nantes - Hopital Nord Laennec
Coordinator of this site? Confirm its status
NantesFranceNot yet recruiting
Institut Montsouris
Coordinator of this site? Confirm its status
ParisFranceNot yet recruiting
CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévèque
Coordinator of this site? Confirm its status
PessacFranceNot yet recruiting
CHU de Poitiers - Centre Cardiovasculaire
Coordinator of this site? Confirm its status
PoitiersFranceRecruiting
CHU de Rennes - Hôpital Pontchallou
Coordinator of this site? Confirm its status
RennesFranceNot yet recruiting
CHU de Rouen - Hôpital Charles Nicolle
Coordinator of this site? Confirm its status
RouenFranceRecruiting
Institut Arnault Tzanck
Coordinator of this site? Confirm its status
Saint-Laurent-du-VarFranceNot yet recruiting
CHRU de Nancy - Hopitaux de Brabois
Coordinator of this site? Confirm its status
Vandœuvre-lès-NancyFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.