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 | Recruiting

• 1 other identifier: 2023-01
• Study Type: interventional
• Target: 266
• Locations: 2 countries
• Sites: 15

Brief 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

Heart Failure With Preserved Ejection Fraction; Atrial Fibrillation, Persistent

Keywords

Heart failure; Cardiac Resynchronization Therapy; Conduction System Pacing

Outcome Measures

Primary Outcomes (1)

• Time to the composite of all-cause mortality or hospitalization due to heart failure or intravenous diuretics.

  Delay between randomization and death or hospitalization or intravenous diuretics due to heart failure

  24 months

Secondary Outcomes (7)

• Time to all-cause mortality

  24 months

• Time to Cardiovascular mortality

  24 months

• Time to heart failure hospitalization

  24 months

• Change in New York Heart Association score

  24 months

• Change in B-type natriuretic peptide level

  24 months

Study Arms (2)

Intervention group with pacemaker implantation and atrioventricular node ablation

EXPERIMENTAL

Pacemaker implantation and atrioventricular node ablation will be performed within a one week period after the randomization.Pharmacological heart failure therapy will be optimized according to current guidelines.

Procedure: pacemaker implantation; Procedure: atrioventricular node ablation; Device: Pacemaker programming

Control

NO INTERVENTION

Conventional care support. The rate control therapy will be optimized to achieve a resting heart rate of \<110 beats per minute. Pharmacological heart failure therapy will be optimized according to current guidelines.

Interventions

pacemaker implantation PROCEDURE

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.

Intervention group with pacemaker implantation and atrioventricular node ablation

atrioventricular node ablation PROCEDURE

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.

Intervention group with pacemaker implantation and atrioventricular node ablation

Pacemaker programming DEVICE

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

Intervention group with pacemaker implantation and atrioventricular node ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French Cardiology Society: lead
• Medtronic France SAS: collaborator
• ClinSearch: collaborator

Study Sites (15)

OLV Aalst

Aalst, 9300, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

Clinique St Pierre Ottignies

Ottignies-Louvain-la-Neuve, 1340, Belgium

NOT YET RECRUITING

CHRU de Brest - Hôpital de la Cavale Blanche

Brest, 29200, France

NOT YET RECRUITING

CHRU de Caen

Caen, 14000, France

NOT YET RECRUITING

CHRU de Tours - Trousseau

Chambray-lès-Tours, 37170, France

NOT YET RECRUITING

CHU Grenoble Alpes

Grenoble, 38043, France

NOT YET RECRUITING

Groupe Hospitalier La Rochelle-Ré-Aunis

La Rochelle, 17019, France

NOT YET RECRUITING

CHRU Lille

Lille, 59000, France

NOT YET RECRUITING

GHICL Allome - Hôpital St Philibert

Lomme, 59462, France

NOT YET RECRUITING

Clinique Millenaire

Montpellier, 34000, France

NOT YET RECRUITING

CHU de Nantes - Hôpital Nord Laennec

Nantes, 44093, France

NOT YET RECRUITING

CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévèque

Pessac, 33604, France

NOT YET RECRUITING

CHU Poitiers

Poitiers, 86021, France

RECRUITING

CHU de Rouen

Rouen, 76000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frédéric ANSELME, MD

  CHU de Rouen, France

  PRINCIPAL INVESTIGATOR

• Corentin CHAUMONT, MD

  CHU de Rouen, France

  STUDY DIRECTOR

Central Study Contacts

Tessa BERGOT, MSc

CONTACT

+33144907033; tessa.bergot@sfcardio.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical outcomes will be adjudicated by the investigator and reviewed by the Clinical Events Committee, which will be blinded to treatment received by the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization 1:1 Intervention arm: Conduction system pacing (pacemaker implantation) + atrioventricular node ablation Control arm: optimal pharmacological therapy

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); FR (12)