Stepwise Approach Versus Linear Ablation for Repeat Procedure in Patients With Recurrence of Persistent Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Sponsor
- Deutsches Herzzentrum Muenchen
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Freedom from atrial arrhythmia
Overview
Brief Summary
Catheter ablation of persistent atrial fibrillation (AF) remains a challenging procedure. Even in experienced centres, repeat interventions are necessary in up to 70 of patients to achieve sinus rhythm at a long-term follow-up.
While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for the ablation of paroxysmal and persistent AF ablation, different additional ablation strategies are used to achieve a modification of the substrate that perpetuates the arrhythmia: linear lesions (anterior and roof lines) or ablation of complex fractionated atrial electrograms (CFAE). In the stepwise approach PVI, CFAE ablation and/or LL are combined according to the presenting arrhythmia during procedure.
The aim of the study is to determine whether there is a difference in terms of freedom from arrhythmia between a stepwise approach and a linear ablation for repeat procedure in patient with recurrence of persistent atrial fibrillation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with recurrence of symptomatic persistent atrial fibrillation after at least one ablation procedure,
- •with the last ablation procedure at least 3 months ago.
- •at least one unsuccessful attempt of antiarrhythmic drug
- •oral anticoagulation for at least 4 weeks prior to ablation
Exclusion Criteria
- •LA thrombus
Outcomes
Primary Outcomes
Freedom from atrial arrhythmia
Documented freedom from atrial arrhythmia (AF or AT) during follow-up.
Secondary Outcomes
- Procedural and safety data