Overview
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)
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.
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).
Eligibility
Inclusion Criteria:
- Age ≥ 18 years
- Persistent or Long-standing Persistent AF
- Dilated left atrium
- Suitable for either procedure
Exclusion Criteria:
- 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 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, breast-feeding, 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