Atrial fibrillation ablation versus heart rate control using conduction system pacing with ablation of the atrioventricular node

Not Applicable

• Conditions: Persistent atrial fibrillation and heart failure; Circulatory System

• Registration Number: ISRCTN65526476
• Lead Sponsor: niversity Hospital of Geneva

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-05
• Last Update Posted: 19 August 2024
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 220

Inclusion Criteria

1. Persistent AF with symptomatic HF despite medical therapy, considered to be suitable for AF ablation, with at most one previous PVI procedure
2. At least one prior hospital admission, or emergency room / HF clinic visit for HF in the past 2 years, with NT-pro-BNP >1000 pg/ml or BNP >250 pg/ml measured at any timepoint during this interval
3. Previous or current rate or rhythm control drug therapy
4. Considered eligible for CSP implantation as an alternative to AF ablation
5. Age > or = 60 years

Exclusion Criteria

1. NYHA Class IV and systolic blood pressure =80 mmHg despite optimized therapy
2. Life expectancy <2 years
3. Need for major surgical intervention
4. Myocardial infarction, stroke or percutaneous coronary intervention within the previous 3 months
5. Previously implanted or planned implantation of CRT device or pacemaker. Implantable cardioverter defibrillator (ICD) implantation without a pacing indication is acceptable.
6. Participation in another controlled trial
7. Inability to sign an informed consent form

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following primary endpoints are assessed at the last follow-up/study closure:<br>1. The composite of all-cause death and CVH (superiority hypothesis)<br>2. The composite of all-cause death and HFH (non-inferiority hypothesis)