Actively Recruiting
A Randomised Controlled Trial Comparing Convergent Hybrid Ablation to Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure
Led by St. George's Hospital, London · Updated on 2025-11-28
120
Participants Needed
7
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a staged hybrid ablation procedure compared to the standard catheter ablation in patients with non-paroxysmal atrial fibrillation (AF) and heart failure. This randomized controlled trial aims to determine which approach better prevents persistent atrial arrhythmia over a follow-up period extending to 24 months after treatment. Participants will be randomly assigned to one of two treatment groups. One group will undergo a staged convergent hybrid ablation, consisting of a minimally invasive surgical epicardial ablation with optional left atrial appendage exclusion followed by an endocardial catheter ablation. The other group will receive the standard percutaneous endocardial catheter ablation alone. The trial compares these two device-based procedures to assess their impact on heart rhythm and heart function. During the study, participants will be closely monitored for heart rhythm changes, heart chamber remodeling, and quality of life using various assessments before treatment and at 12 and 24 months afterward. The main outcome measured is freedom from persistent atrial arrhythmia after a single procedure without certain medications. Safety is also tracked within 30 days and beyond. Overall, the trial will last at least two years for each participant, including follow-up evaluations at multiple time points.
CONDITIONS
Brief Title
Hybrid Ablation of Atrial Fibrillation in Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Persistent or long-standing persistent atrial fibrillation
- Moderately or more dilated left atrium
- Suitable for either the staged hybrid ablation or standard catheter ablation procedure
- Left ventricular ejection fraction less than 50%
You will not qualify if you...
- Not optimized medically or lifestyle-wise for atrial fibrillation or heart failure
- Unable to provide written consent
- Previous open-heart surgery
- Active infection, esophageal ulcer, stricture, or varices
- Prior catheter ablation of atrial fibrillation
- Contraindication to anticoagulation or active left atrial thrombus despite treatment
- Severe valvular heart disease
- Unstable coronary artery disease
- Uncontrolled ventricular arrhythmia
- Heart attack or stroke within the last 90 days
- Pregnant, breastfeeding, or planning pregnancy within six months
- Severe other health condition or implanted device preventing trial procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months with assessment after a 3-month blanking period
Participants undergo either the staged Convergent hybrid ablation procedure involving a minimally-invasive surgical epicardial ablation followed by endocardial catheter ablation, or standard endocardial catheter ablation for atrial fibrillation and heart failure.
1 to 2 procedure visits depending on treatment assignment and follow-up visits at 12 and 24 months
Trial Site Locations
Total: 7 locations
1
Ashford & St Peters Hospital NHS Trust
Chertsey, United Kingdom
Actively Recruiting
2
Epsom General Hospital
Epsom, United Kingdom
Actively Recruiting
3
Cromwell Hospital
London, United Kingdom
Active, Not Recruiting
4
Royal Surrey County Hospital
London, United Kingdom
Actively Recruiting
5
St Anthonys Hospital
London, United Kingdom
Active, Not Recruiting
6
St Georges at Kingston Hospital
London, United Kingdom
Actively Recruiting
7
St Georges University of London
London, United Kingdom
Actively Recruiting
Research Team
R
Riyaz A Kaba
O
Omar Ahmed
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here