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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
OLV Aalst
NOT_YET_RECRUITING
Aalst
UZ Leuven
NOT_YET_RECRUITING
Leuven
Clinique St Pierre Ottignies
NOT_YET_RECRUITING
Ottignies-louvain-la-neuve
France
CHRU de Brest - Hôpital de la Cavale Blanche
NOT_YET_RECRUITING
Brest
CHRU de Caen
NOT_YET_RECRUITING
Caen
CHRU de Tours - Trousseau
NOT_YET_RECRUITING
Chambray-lès-tours
CHU Grenoble Alpes
NOT_YET_RECRUITING
Grenoble
Groupe Hospitalier La Rochelle-Ré-Aunis
NOT_YET_RECRUITING
La Rochelle
CHRU Lille
NOT_YET_RECRUITING
Lille
GHICL Allome - Hôpital St Philibert
NOT_YET_RECRUITING
Lomme
Clinique Millenaire
NOT_YET_RECRUITING
Montpellier
CHU de Nantes - Hôpital Nord Laennec
NOT_YET_RECRUITING
Nantes
CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévèque
NOT_YET_RECRUITING
Pessac
CHU Poitiers
RECRUITING
Poitiers
CHU de Rouen
NOT_YET_RECRUITING
Rouen
Contact Information
Primary
Tessa BERGOT, MSc
tessa.bergot@sfcardio.fr
+33144907033
Time Frame
Start Date: 2025-09-10
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 266
Treatments
Experimental: Intervention group with pacemaker implantation and atrioventricular node ablation
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.
No_intervention: Control
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.
Sponsors
Leads: French Cardiology Society
Collaborators: ClinSearch, Medtronic France SAS

This content was sourced from clinicaltrials.gov

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