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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Minimally-invasive epicardial ablation +/- left atrial appendage exclusion using an epicardial clip, combined with endocardial radiofrequency catheter ablation
Standard percutaneous endocardial catheter ablation of atrial fibrillation
Ashford & St Peters Hospital NHS Trust
Chertsey, United Kingdom
RECRUITINGEpsom General Hospital
Epsom, United Kingdom
RECRUITINGCromwell Hospital
London, United Kingdom
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
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Royal Surrey County Hospital
London, United Kingdom
RECRUITINGSt Anthonys Hospital
London, United Kingdom
ACTIVE_NOT_RECRUITINGSt Georges at Kingston Hospital
London, United Kingdom
RECRUITINGSt Georges University of London
London, United Kingdom
RECRUITINGTime 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