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

Atrial Fibrillation Clinical Trial

— TARGET  

Official title:

Does AF Termination Without Additional Ablation Influence Outcome?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01696344
• Other study ID #: TCAI_TARGET
• Status: Active, not recruiting
• Start date: May 2012
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• PVAI

• PVAI + ablation of extraPV triggers
PVAI 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

Locations

Country	Name	City	State
United States	St. david's Medical Center	Austin	Texas
United States	Texas Cardiac arrhythmia Institute, St. David's Hospital	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation	California Pacific Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF recurrence	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.	3 years