An interventional study of AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip and Endocardial Catheter Ablation in Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent and Atrial Arrhythmia, sponsored by St. George's Hospital, London. Recruiting at 7 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by St. George's Hospital, London · Not applicable, Interventional, and Treatment
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
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).
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 120 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →St. George's Hospital, London is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Staged Convergent Hybrid Ablation Procedure Stage 1 - Minimally-Invasive Surgical Epicardial Ablation Procedure +/- concomitant LAA exclusion. Stage 2 - Endocardial Catheter Ablation
Device: AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip · Device: Endocardial Catheter Ablation
Standard endocardial catheter ablation
Device: Endocardial Catheter Ablation
Minimally-invasive epicardial ablation +/- left atrial appendage exclusion using an epicardial clip, combined with endocardial radiofrequency catheter ablation
Also known as: Convergent Hybrid Epicardial Endocardial Ablation plus/minus left atrial appendage exclusion
Standard percutaneous endocardial catheter ablation of atrial fibrillation
Also known as: Percutaneous Catheter Ablation
Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications
Recurrence of persistent atrial arrhythmia during follow-up months).
Time frame: Measured from the end of a 3-month blanking period at 12 and 24 months
Safety Endpoint
Safety endpoint of severe and non-severe complications as defined in the protocol
Time frame: Measured as early (within 30- days) and late (> 30 days) after each procedure or part of procedure
Freedom from any atrial arrhythmia lasting > 30 seconds after a single completed procedure on class I/III medications
Recurrence of any atrial arrhythmia \> 30 seconds on or off class I / III medications, considering any repeat ablation procedures
Time frame: Measured from the end of a 3- month blanking period at 12 and 24 months
Freedom from atrial arrhythmias after any redo procedures (on or off class I or III medications)
Recurrence of any atrial arrhythmia \> 30 seconds on or off class I / III medications, considering any repeat ablation procedures
Time frame: Measured from the end of a 3- month blanking period at 12 and 24 months
To assess left ventricular structural remodelling and change in ventricular function in response to either procedure
Left ventricular ejection fraction as recorded on transthoracic echocardiography (TTE)
Time frame: Pre-procedure and at 12 and 24 months post-procedure
To assess left atrial remodelling in response to either technique.
Left atrial dimensions/function on Echocardiography
Time frame: Pre-procedure and up to 12 and 24 months post-procedure
To evaluate the effects of the interventions on the patient's symptoms and quality of life (EHRA Score)
Change in European Heart Rhythm Association (EHRA) AF Symptom score
Time frame: Pre-procedure and at 12 and 24 months post-procedure
To evaluate the effects of the interventions on the patient's symptoms and quality of life (NYHA Class).
Change in New York Heart Association (NYHA) class
Time frame: Pre-procedure and at 12 and 24 months post-procedure
To evaluate the effects of the interventions on the patient's quality of life (EQ5D)
Change in EuroQol Quality of life Score (EQ5D)
Time frame: Pre-procedure and at 12 and 24 months post-procedure
To evaluate the effects of the interventions on the patient's quality of life (AFEQT)
Change in Atrial Fibrillation Effect on Quality of Life Score (AFEQT)
Time frame: Pre-procedure and at 12 and 24 months post-procedure
Plan to share: No
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St. George's Hospital, London