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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convergent Hybrid Ablation +/- Left Atrial Appendage Exclusion | Experimental | Staged Convergent Hybrid Ablation Procedure Stage 1 - Minimally-Invasive Surgical Epicardial Ablation Procedure +/- concomitant LAA exclusion. Stage 2 - Endocardial Catheter Ablation |
|
| Standard Endocardial Catheter Ablation | Active Comparator | Standard endocardial catheter ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip | Device | Minimally-invasive epicardial ablation +/- left atrial appendage exclusion using an epicardial clip, combined with endocardial radiofrequency catheter ablation |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Measured from the end of a 3-month blanking period at 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | Safety endpoint of severe and non-severe complications as defined in the protocol | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Riyaz A Kaba | Contact | 020 8725 4571 | rkaba@sgul.ac.uk | |
| Omar Ahmed | Contact | 020 8725 4571 | m2109536@sgul.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Riyaz A Kaba | St Georges Hospital NHS Trust | Principal Investigator |
| Omar Ahmed | St Georges Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ashford & St Peters Hospital NHS Trust | Recruiting | Chertsey | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42216292 | Derived | Ahmed O, Behr ER, White S, Momin A, Kaba RA MBChB, FRCP. Convergent Hybrid Ablation Versus Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure: HALT AF Study Protocol and Rationale for a Multicenter Randomized Controlled Trial. J Am Heart Assoc. 2026 Jun 2;15(11):e047774. doi: 10.1161/JAHA.125.047774. Epub 2026 May 29. |
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Clinical study. 1:1 randomised. Convergent Hybrid Ablation Procedure versus standalone endocardial catheter ablation).
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|
| Endocardial Catheter Ablation | Device | Standard percutaneous endocardial catheter ablation of atrial fibrillation |
|
|
Recurrence of any atrial arrhythmia > 30 seconds on or off class I / III medications, considering any repeat ablation procedures |
| 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 | 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) | 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 | 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 | 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 | 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) | 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) | Pre-procedure and at 12 and 24 months post-procedure |
| Epsom General Hospital | Recruiting | Epsom | United Kingdom |
|
| Cromwell Hospital | Active, not recruiting | London | United Kingdom |
| Royal Surrey County Hospital | Recruiting | London | United Kingdom |
|
| St Anthonys Hospital | Active, not recruiting | London | United Kingdom |
| St Georges at Kingston Hospital | Recruiting | London | United Kingdom |
|
| St Georges University of London | Recruiting | London | United Kingdom |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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