NCT05411614

Hybrid Ablation of Atrial Fibrillation in Heart Failure

A Randomised Controlled Trial Comparing Convergent Hybrid Ablation to Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: St. George's Hospital, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomised controlled trial to assess the efficacy of staged hybrid ablation when compared with standard catheter ablation in patients with non-paroxysmal atrial fibrillation (AF) and Heart Failure

Detailed description

The objective of this randomized study is to evaluate the safety and efficacy of Convergent hybrid ablation when compared to standard catheter ablation in patients with non-paroxysmal AF and heart failure. Patients will be randomised in a 1:1 ratio. The primary efficacy endpoint will be freedom from persistent atrial arrhythmia (measured from the end of a 3-month blanking period up to 24 months (12 and 24 months).

Conditions

• Persistent Atrial Fibrillation
• Atrial Fibrillation, Persistent
• Atrial Arrhythmia
• Atrial Fibrillation
• Heart Failure
• Left Ventricular (LV) Systolic Dysfunction

Interventions

Type	Name	Description
DEVICE	AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip	Minimally-invasive epicardial ablation +/- left atrial appendage exclusion using an epicardial clip, combined with endocardial radiofrequency catheter ablation
DEVICE	Endocardial Catheter Ablation	Standard percutaneous endocardial catheter ablation of atrial fibrillation

Timeline

• Start date: 2022-06-25
• Primary completion: 2026-05-01
• Completion: 2027-10-01
• First posted: 2022-06-09
• Last updated: 2025-11-28

Locations

7 sites across 1 country: United Kingdom