Atrioventricular Node Ablation and Conduction System Pacing in Patients With Well Controll
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 regula
| Condition(s) | Heart Failure With Preserved Ejection Fraction, Atrial Fibrillation, Persistent |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | French Cardiology Society |
| Locations | Aalst, Belgium; Leuven, Belgium; Ottignies-Louvain-la-Neuve, Belgium; Brest, France; Caen, France; Chambray-lès-Tours, France (+9 more sites) |
| Start date | 2025-09-10 |
| NCT ID | NCT06833138 |
| Official listing | https://clinicaltrials.gov/study/NCT06833138 |