Actively Recruiting
Atrioventricular Node Ablation and Conduction System Pacing in Patients With Well Controlled Permanent Atrial Fibrillation, Heart Failure, and Preserved Ejection Fraction: Heart Rate Regularization vs Medical Rate Control
Led by French Cardiology Society · Updated on 2025-09-22
266
Participants Needed
15
Research Sites
30 weeks
Total Duration
On this page
Sponsors
F
French Cardiology Society
Lead Sponsor
M
Medtronic France SAS
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness of combining physiological pacing with atrioventricular node ablation in patients who have heart failure with preserved ejection fraction (HFpEF) and well-controlled permanent atrial fibrillation. The study aims to determine if this combination can reduce mortality and hospitalizations for heart failure compared to standard drug therapy. This research focuses on heart rate regularization to prevent the harmful effects of right ventricular apical pacing in this patient group. Participants will be randomly assigned to one of two groups: the intervention group receiving pacemaker implantation and atrioventricular node ablation, or the control group receiving optimized drug therapy. The pacemaker will be programmed in VVIR mode with a set lower rate. Procedures will occur within one week after randomization, and drug therapies will be adjusted according to current guidelines in both groups. During the study, participants will visit the clinic at 3, 12, and 24 months after randomization for checkups and tests. Researchers will monitor time to the combined outcome of death, heart failure hospitalizations, or use of intravenous diuretics over 24 months. Secondary measures include changes in heart function scores, biomarker levels, and adverse events related to the procedures. The total follow-up period is 24 months.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Permanent atrial fibrillation lasting more than 6 months
- Left Ventricular Ejection Fraction of 50% or higher
- At least one heart failure hospitalization in the past year
- New York Heart Association (NYHA) score of 2 or higher
- Presence of at least one diastolic dysfunction criterion (E/e' ratio > 9, elevated left ventricular mass, or elevated B-type natriuretic peptide levels)
- Narrow QRS duration of 120 milliseconds or less
- Average heart rate of 110 beats per minute or less on 24-hour Holter monitoring
- Age 18 years or older
- Ability to understand the study and give informed consent
- Covered by social insurance
- Use of effective contraception and negative pregnancy test for women of childbearing age
You will not qualify if you...
- Eligible for atrial fibrillation catheter ablation
- Life expectancy less than 12 months
- Severe chronic kidney disease (estimated glomerular filtration rate 20 ml/min/1.73 m2 or less)
- Severe respiratory disease (severe COPD with GOLD stage 3 or higher and/or chronic oxygen therapy)
- Class III obesity (Body Mass Index 40 or higher)
- Confirmed or suspected infiltrative cardiomyopathy (such as amyloidosis, sarcoidosis, Fabry disease)
- Obstructive hypertrophic cardiomyopathy
- Previous implanted cardiac devices (pacemaker, defibrillator, or resynchronization therapy)
- Other indications for pacemaker or defibrillator implantation
- Ambulatory status less than 50% of the time
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants in the intervention group receive pacemaker implantation and atrioventricular node ablation within one week after randomization. The pacemaker is programmed for physiological pacing. Participants in the control group receive optimized pharmacological rate control therapy.
Initial procedure visit plus follow-up visits as scheduled during treatment
Duration - Up to 24 months after treatment initiation
Participants are monitored for outcomes including mortality, heart failure hospitalizations, and adverse events following treatment.
Regular follow-up visits during the study period
Trial Site Locations
Total: 15 locations
1
OLV Aalst
Aalst, Belgium, 9300
Not Yet Recruiting
2
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
3
Clinique St Pierre Ottignies
Ottignies-Louvain-la-Neuve, Belgium, 1340
Not Yet Recruiting
4
CHRU de Brest - Hôpital de la Cavale Blanche
Brest, France, 29200
Not Yet Recruiting
5
CHRU de Caen
Caen, France, 14000
Not Yet Recruiting
6
CHRU de Tours - Trousseau
Chambray-lès-Tours, France, 37170
Not Yet Recruiting
7
CHU Grenoble Alpes
Grenoble, France, 38043
Not Yet Recruiting
8
Groupe Hospitalier La Rochelle-Ré-Aunis
La Rochelle, France, 17019
Not Yet Recruiting
9
CHRU Lille
Lille, France, 59000
Not Yet Recruiting
10
GHICL Allome - Hôpital St Philibert
Lomme, France, 59462
Not Yet Recruiting
11
Clinique Millenaire
Montpellier, France, 34000
Not Yet Recruiting
12
CHU de Nantes - Hôpital Nord Laennec
Nantes, France, 44093
Not Yet Recruiting
13
CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévèque
Pessac, France, 33604
Not Yet Recruiting
14
CHU Poitiers
Poitiers, France, 86021
Actively Recruiting
15
CHU de Rouen
Rouen, France, 76000
Not Yet Recruiting
Research Team
T
Tessa BERGOT, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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