Overview

This trial is active, not recruiting.

Conditions persistent atrial fibrillation, long-standing persistent atrial fibrillation
Treatments pulmonary vein antrum isolation, cfae ablation, isolation of non-pv triggers
Phase phase 3
Sponsor Texas Cardiac Arrhythmia Research Foundation
Collaborator California Pacific Medical Center
Start date February 2013
End date March 2017
Trial size 186 participants
Trial identifier NCT01672138, TANTRA_TCAI

Summary

This study aims to examine the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation patients using different ablation strategies such as 1) PVAI alone, 2) PVAI+ CFAE, 3) PVAI+ CFAE+ non-PV trigger ablation.

[ PVAI: Pulmonary Vein Antrum Isolation CFAE: Complex Fractionated Atrial Electrograms Non-PV triggers: Triggers arising from sites other than pulmonary veins]

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Pulmonary Vein Antrum Isolation alone
pulmonary vein antrum isolation PVAI
Radio-frequency catheter ablation of pulmonary vein antrum
(Active Comparator)
PVAI+ CFAE ablation
pulmonary vein antrum isolation PVAI
Radio-frequency catheter ablation of pulmonary vein antrum
cfae ablation CFAE
Catheter ablation of CFAEs
(Active Comparator)
PVAI + CFAE + non-PV triggers ablation
pulmonary vein antrum isolation PVAI
Radio-frequency catheter ablation of pulmonary vein antrum
cfae ablation CFAE
Catheter ablation of CFAEs
isolation of non-pv triggers Non-PV triggers ablation
Catheter ablation of triggers originating from extra-PV sites

Primary Outcomes

Measure
Recurrence of atrial arrhythmia
time frame: 3 years

Secondary Outcomes

Measure
Improvement in quality of life
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: 1. Age ≥ 18 years 2. Patients presenting with drug-refractory long-standing persistent AF (LSPAF) 3. Ability to understand and provide signed informed consent Exclusion Criteria: 1. Previous catheter ablation or MAZE procedure in left atrium 2. Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc

Additional Information

Official title PVAI Plus Isolation of CAFEs and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation
Principal investigator Andrea Natale, MD
Description Back ground: Pulmonary vein antrum isolation (PVAI) as a lone procedure, is known to have limited success rate in terms of long-term recurrence-free survival in non-paroxysmal atrial fibrillation (NPAF) and additional ablations isolating extra-PV triggers seem to improve the outcome (1). The extra-PV triggers include complex fractionated atrial electrograms (CFAEs) and triggers from other sites such as left atrial posterior wall, superior vena cava, left atrial appendage, ligament of Marshall and coronary sinus (1, 2). These are known to be independent predictors of late AF recurrence following catheter ablation (3, 4, and 5). In a meta-analysis of several studies comparing long-term efficacy of different ablation strategies, Li et al have reported superior success rate of combined CFAE ablation and standard PVAI in maintaining long-term sinus-rhythm (6). Similarly, earlier studies have demonstrated better ablation outcome in NPAF when non-PV triggers sites were isolated along with PVAI (5, 7). However, limited data is available showing a comparison of the lasting efficacy of the above three procedures when used in different combinations. Hypothesis: The combined ablation strategy including PVAI, ablation of CFAE and extra-PV triggers has the highest likelihood of maintaining long-term sinus rhythm in patients with NPAF.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation.