Strategies in Patients Undergoing Repeat AF Ablation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Pennsylvania
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Primary efficacy endpoint
Study Overview
Brief Summary
The aim of the proposed research project is to compare the efficacy of three different ablation strategies in patients with atrial fibrillation (AF) who are undergoing their first repeat catheter ablation for recurrent AF.
Detailed Description
Reconnection of the pulmonary veins (PV) is generally responsible for AF recurrence in most cases. However, in a growing subset of patients undergoing repeat ablation for recurrent AF, the PVs are chronically isolated and no other non-PV triggers of AF can be identified. The investigators have previously shown that empirically ablating at known common non-PV trigger sites for AF can improve arrhythmia free survival beyond PVI. The left atrial (LA) posterior wall is also increasingly being isolated in AF patients undergoing catheter ablation. However, long term arrhythmia free survival in AF patients undergoing LA posterior wall isolation is not consistently better than PVI alone.
The objective of this study therefore is to assess whether performing empiric ablation of common non-PV trigger sites or achieving LA posterior wall isolation can improve arrhythmia free survival in AF patients who are undergoing repeat AF ablation and in whom the PV remain chronically isolated and/or do not demonstrate AF. The investigators propose to do this as prospective, randomized three arm study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
patients will be blinded to strategy used
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients undergoing first redo AF ablation who have chronically isolated pulmonary veins and no non-PV triggers with provocation testing (randomized intra-procedure).
Exclusion Criteria
- •Patients in whom ≥1 PVs have reconnected and AF triggers can be elicited from the reconnected PV.
- •Patients who demonstrated non-PV triggers for AF.
- •Patients who have experienced arrhythmia recurrence post ablation where the recurrent arrhythmia is other than atrial fibrillation or typical atrial flutter
- •Failure to obtain informed consent
- •Patients with a mechanical mitral valve
Arms & Interventions
CTI/AAD (control)
In all arms, patients are undergoing first redo AF ablation and the pulmonary veins are chronically isolated and no non-PV triggers elicited during provocation. Arm 1- Cavo-tricuspid isthmus (CTI) ablation with adjustment and/or optimization of antiarrhythmic drug regimen where possible (control arm)
Intervention: Ablation (Procedure)
Posterior wall isolation
In all arms, patients are undergoing first redo AF ablation and the pulmonary veins are chronically isolated and no non-PV triggers elicited during provocation. Arm 2-LA Posterior wall isolation by creation of a LA roof and floor line
Intervention: Ablation (Procedure)
Empiric Isolation of common trigger sites
In all arms, patients are undergoing first redo AF ablation and the pulmonary veins are chronically isolated and no non-PV triggers elicited during provocation. Arm 3-empiric ablation of common sites of non-PV triggers of AF in both the right and left atria.
Intervention: Ablation (Procedure)
Outcomes
Primary Outcomes
Primary efficacy endpoint
Time Frame: 1 year
Freedom from atrial arrhythmias off antiarrhythmic medications at 1 year after 1 repeat ablation procedure. Subjects are seen at 6 weeks, 6 months and 1 year post procedure with ECG at each visit and monitors at 6 months and one year to assess efficacy. Information regarding medications, health status, arrhythmia symptoms, and ECG and monitor results documented.
Secondary Outcomes
- Secondary endpoint(1 year)