Clinical Trials Directory

Trials / Unknown

UnknownNCT01696344

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

Does AF Termination Without Additional Ablation Influence Outcome?

Status
Unknown
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
Texas Cardiac Arrhythmia Research Foundation · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPVAI
PROCEDUREPVAI + ablation of extraPV triggersPVAI followed by ablation of extra-PV triggers originating from sites other than pulmonary veins such as superior vena cava, ligament of Marshall, coronary sinus, crista terminalis, left atrial (LA) posterior wall and LA appendage

Timeline

Start date
2012-05-01
Primary completion
2018-12-01
Completion
2019-12-01
First posted
2012-10-01
Last updated
2019-04-10

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01696344. Inclusion in this directory is not an endorsement.