Atrial Arrhythmia, Atrial Fibrillation, Atrial Fibrillation, Persistent, Heart Failure, Left Ventricular (LV) Systolic Dysfunction, Persistent Atrial Fibrillation
Conditions
Brief summary
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
Detailed description
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).
Interventions
DEVICEAtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip
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
Sponsors
St. George's Hospital, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Clinical study. 1:1 randomised. Convergent Hybrid Ablation Procedure versus standalone endocardial catheter ablation).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications | Measured from the end of a 3-month blanking period at 12 and 24 months | Recurrence of persistent atrial arrhythmia during follow-up months). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from any atrial arrhythmia lasting > 30 seconds after a single completed procedure on class I/III medications | Measured from the end of a 3- month blanking period at 12 and 24 months | Recurrence of any atrial arrhythmia \> 30 seconds on or off class I / III medications, considering any repeat ablation procedures |
| Freedom from atrial arrhythmias after any redo procedures (on or off class I or III medications) | Measured from the end of a 3- month blanking period at 12 and 24 months | Recurrence of any atrial arrhythmia \> 30 seconds on or off class I / III medications, considering any repeat ablation procedures |
| To assess left ventricular structural remodelling and change in ventricular function in response to either procedure | Pre-procedure and at 12 and 24 months post-procedure | Left ventricular ejection fraction as recorded on transthoracic echocardiography (TTE) |
| To assess left atrial remodelling in response to either technique. | Pre-procedure and up to 12 and 24 months post-procedure | Left atrial dimensions/function on Echocardiography |
| Safety Endpoint | Measured as early (within 30- days) and late (> 30 days) after each procedure or part of procedure | Safety endpoint of severe and non-severe complications as defined in the protocol |
| To evaluate the effects of the interventions on the patient's symptoms and quality of life (NYHA Class). | Pre-procedure and at 12 and 24 months post-procedure | Change in New York Heart Association (NYHA) class |
| To evaluate the effects of the interventions on the patient's quality of life (EQ5D) | Pre-procedure and at 12 and 24 months post-procedure | Change in EuroQol Quality of life Score (EQ5D) |
| To evaluate the effects of the interventions on the patient's quality of life (AFEQT) | Pre-procedure and at 12 and 24 months post-procedure | Change in Atrial Fibrillation Effect on Quality of Life Score (AFEQT) |
| To evaluate the effects of the interventions on the patient's symptoms and quality of life (EHRA Score) | Pre-procedure and at 12 and 24 months post-procedure | Change in European Heart Rhythm Association (EHRA) AF Symptom score |
Countries
United Kingdom
Contacts
Primary ContactRiyaz A Kaba
Backup ContactOmar Ahmed
Outcome results
None listed