Hybrid ablation for treating persistent atrial fibrillation
A Randomised Controlled Trial Comparing Convergent Hybrid Ablation to Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure
This study is testing a new hybrid treatment for people with persistent atrial fibrillation to see if it works better than the standard catheter procedure in helping them stay free from heart rhythm problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. George's Hospital, London Academic / other |
| Locations | 7 sites (Chertsey and 6 other locations) |
| Trial ID | NCT05411614 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the safety and efficacy of a staged hybrid ablation technique compared to standard catheter ablation in patients with non-paroxysmal atrial fibrillation. Participants will be randomly assigned to one of the two treatment groups in a 1:1 ratio. The primary goal is to determine the freedom from persistent atrial arrhythmia over a 24-month period, following a 3-month blanking phase. The study will utilize the AtriCure EPi-Sense-AF Guided Coagulation System and endocardial catheter ablation as part of the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with persistent or long-standing persistent atrial fibrillation and a dilated left atrium.
Not a fit: Patients who have had previous open-heart surgery or those with severe concomitant conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients suffering from persistent atrial fibrillation.
How similar studies have performed: Other studies have shown promising results with hybrid ablation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Persistent or Long-standing Persistent AF * Dilated left atrium (at least moderately dilated) * Suitable for either procedure * LVEF \< 50% Exclusion Criteria: * Not yet optimised from a medical or lifestyle perspective for AF or heart failure * Unable to provide written consent * Previous open-heart surgery * Active infection, oesophageal ulcer stricture or oesophageal varices * Prior catheter ablation of atrial fibrillation (prior ablation for atrial flutter / supraventricular tachycardia or ventricular arrhythmia acceptable) * Contraindication to anticoagulation, or active thrombus in the left atrium despite therapeutic anticoagulation * Severe valvular heart disease * Unstable coronary artery disease * Uncontrolled ventricular arrhythmia * Heart attack or stroke within the last 90 days * Pregnant, breastfeeding, or women of childbearing age who plan to get pregnant within six months * Severe concomitant condition or presence of an implanted device that would preclude the patient from undergoing trial procedures
Where this trial is running
Chertsey and 6 other locations
- Ashford & St Peters Hospital NHS Trust — Chertsey, United Kingdom (Recruiting)
- Epsom General Hospital — Epsom, United Kingdom (Recruiting)
- Cromwell Hospital — London, United Kingdom (Active_not_recruiting)
- Royal Surrey County Hospital — London, United Kingdom (Recruiting)
- St Anthonys Hospital — London, United Kingdom (Active_not_recruiting)
- St Georges at Kingston Hospital — London, United Kingdom (Recruiting)
- St Georges University of London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Riyaz A Kaba — St Georges Hospital NHS Trust
- Study coordinator: Riyaz A Kaba
- Email: rkaba@sgul.ac.uk
- Phone: 020 8725 4571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.