Atrioventricular node ablation with conduction system pacing versus drug rate control for HFpEF patients with permanent atrial fibrillation
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
This will test whether regularizing heart rate by combining atrioventricular node ablation with physiological (conduction system) pacing lowers deaths or heart-failure hospital stays compared with medication in people with well-controlled permanent atrial fibrillation and HFpEF.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 266 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | French Cardiology Society Academic / other |
| Locations | 15 sites (Aalst and 14 other locations) |
| Trial ID | NCT06833138 on ClinicalTrials.gov |
What this trial studies
Adults with well-controlled permanent atrial fibrillation and heart failure with preserved ejection fraction are randomized to receive either atrioventricular node ablation plus physiological (conduction system) pacing or optimal pharmacological rate control. The trial compares time to a composite endpoint of all-cause mortality, hospitalization for heart failure, or need for intravenous diuretics over a 24-month follow-up. Participants attend clinic visits at baseline and at roughly 3, 12, and 24 months for device checks and outcome assessment. The study targets patients with prior heart-failure hospitalization, preserved LVEF, narrow QRS, and average heart rate ≤110/min on 24-hour Holter monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults with permanent atrial fibrillation for more than 6 months, preserved LVEF (≥50%), at least one heart-failure hospitalization in the prior year, NYHA class ≥2, narrow QRS (≤120 ms), and average heart rate ≤110/min on 24-hour Holter.
Not a fit: Patients eligible for atrial fibrillation catheter ablation, with life expectancy under 12 months, severe uncontrolled comorbidities (for example advanced kidney disease), or those without prior heart-failure hospitalization or with wide QRS are less likely to benefit from this approach.
Why it matters
Potential benefit: If successful, the approach could reduce deaths and heart-failure hospitalizations by stabilizing beat-to-beat heart rate while avoiding the harms of nonphysiological right ventricular pacing.
How similar studies have performed: Previous trials such as APAF-CRT showed mortality and hospitalization benefit from AV node ablation plus cardiac resynchronization therapy in HF with AF, but specific testing of conduction-system (physiological) pacing in HFpEF is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Aalst and 14 other locations
- OLV Aalst — Aalst, Belgium (Not_yet_recruiting)
- UZ Leuven — Leuven, Belgium (Not_yet_recruiting)
- Clinique St Pierre Ottignies — Ottignies-Louvain-la-Neuve, Belgium (Not_yet_recruiting)
- CHRU de Brest - Hôpital de la Cavale Blanche — Brest, France (Not_yet_recruiting)
- CHRU de Caen — Caen, France (Not_yet_recruiting)
- CHRU de Tours - Trousseau — Chambray-lès-Tours, France (Not_yet_recruiting)
- CHU Grenoble Alpes — Grenoble, France (Not_yet_recruiting)
- Groupe Hospitalier La Rochelle-Ré-Aunis — La Rochelle, France (Not_yet_recruiting)
- CHRU Lille — Lille, France (Not_yet_recruiting)
- GHICL Allome - Hôpital St Philibert — Lomme, France (Not_yet_recruiting)
- Clinique Millenaire — Montpellier, France (Not_yet_recruiting)
- CHU de Nantes - Hôpital Nord Laennec — Nantes, France (Not_yet_recruiting)
- CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévèque — Pessac, France (Not_yet_recruiting)
- CHU Poitiers — Poitiers, France (Recruiting)
- CHU de Rouen — Rouen, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Frédéric ANSELME, MD — CHU de Rouen, France
- Study coordinator: Tessa BERGOT, MSc
- Email: tessa.bergot@sfcardio.fr
- Phone: +33144907033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.