Does Atrial Fibrillation (AF) Termination Without Additional Ablation Influence Outcome?

• Conditions: Atrial Fibrillation
• Interventions: Procedure: PVAI; Procedure: PVAI + ablation of extraPV triggers

• Registration Number: NCT01696344
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

Brief Summary

This prospective study aims to investigate if termination of atrial fibrillation (AF) after pulmonary vein antrum isolation (PVAI) without additional ablation of non-PV triggers, in long-standing persistent (LSP) AF, is enough to ensure long-term success.

Detailed Description

Background: AF is a heterogeneous arrhythmia. At its simplest, it is triggered by rapidly firing foci around pulmonary veins (PV) and can be cured by isolation of PV alone. Evidences suggest that when high frequency of atrial activation is maintained for relatively longer period (as in persistent or long-standing AF), ion channel remodeling changes the electrophysiologic substrate and lead to AF permanence. Therefore, PVAI alone, as anticipated, demonstrates to have limited success rate in persistent and LSP AF and additional ablations beyond PVAI involving substrate modification are advocated by many experts in electrophysiology. However, there is yet no consensus on the ablation strategy for long-standing AF. It is still not clear whether AF termination during ablation could be considered as an ablation endpoint or not, as earlier studies have reported results that are at variance with each other. Some studies have suggested that termination of AF during ablation is associated with reduced recurrence of arrhythmia while others detected no association of AF termination with long-term maintenance of sinus rhythm (SR) in persistent or LSP-AF.Therefore this study aims to examine ablation outcomes in LSP-AF patients with AF termination with or without additional ablation of extra-PV triggers.

Hypothesis: AF termination does not eliminate the need for additional ablations in achieving long-term ablation success in LSP-AF.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-01
• Primary Completion: 2018-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age ≥ 18 years
2. LSP-AF patients experiencing AF termination during ablation
3. Ability to understand and provide signed informed consent

Exclusion Criteria

1. Previous left atrial catheter ablation or MAZE procedure in left atrium
2. Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	PVAI	No additional ablation after AF termination(PVAI only)
Cohort 2	PVAI + ablation of extraPV triggers	Additional ablation of extra-PV triggers before and after isoproterenol-challenge after AF termination (PVAI + ablation of extra-PV triggers)

Primary Outcome Measures

Name	Time	Method
AF recurrence	3 years	Any episode of AF/AT longer than 30 seconds will be considered as recurrence. Episodes that occur during the first 3 months of the procedure (blanking period) will not be considered as recurrence.

Trial Locations

Locations (2)

St. david's Medical Center; 🇺🇸 Austin, Texas, United States

Texas Cardiac arrhythmia Institute, St. David's Hospital; 🇺🇸 Austin, Texas, United States