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

Launched by FRENCH CARDIOLOGY SOCIETY · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a specific treatment approach for patients with heart failure and a condition called permanent atrial fibrillation, which is an irregular heartbeat that has been well-managed for at least six months. The researchers want to see if a combination of a procedure called atrioventricular node ablation and a type of pacing that mimics the heart's natural rhythm can help reduce the risk of death and hospital visits for heart failure compared to standard medication treatment. The trial will last for two years and will involve regular check-ups at three, twelve, and twenty-four months.

To participate, you need to be at least 18 years old, have had permanent atrial fibrillation for more than six months, and have a specific level of heart function measured by tests. You should have experienced at least one hospital stay for heart failure in the past year. However, certain conditions, like severe kidney disease or previous heart device implants, would exclude you from joining. This study is not yet recruiting, but it represents an important step in exploring new treatment options for heart health.

Gender

ALL

Eligibility 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