Actively Recruiting
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
Led by French Cardiology Society · Updated on 2025-09-22
266
Participants Needed
15
Research Sites
224 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
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
Official 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 previous year
- New York Heart Association (NYHA) score of 2 or higher
- At least one criterion related to diastolic dysfunction: E/e' ratio over 9, or elevated left ventricular mass, or elevated NT pro BNP or BNP levels
- Narrow QRS duration of 120 ms or less
- Average heart rate of 110 beats per minute or less on 24-hour Holter monitoring
- Age over 18 years
- Ability to understand and give informed consent
- Coverage by social insurance
- 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 with estimated glomerular filtration rate 20 ml/1.73 m2 or less
- Severe respiratory disease such as severe COPD with Gold stage 3 or higher, or chronic oxygen therapy
- Class III obesity with body mass index 40 or higher
- Confirmed or suspected infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis, Fabry disease)
- Obstructive hypertrophic cardiomyopathy
- Previously implanted cardiac devices such as pacemaker or defibrillator
- Other indications for pacemaker implantation
- Indication for implantable cardioverter-defibrillator
- Being ambulatory 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
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here