TANTRAPVAI Plus Scar Homogenization and Ablation of Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation
Pulmonary Vein Antrum Isolation
+ Pulmonary Vein Antrum Isolation
+ scar homogenization
Arrhythmias, Cardiac+3
+ Cardiovascular Diseases
+ Heart Diseases
Treatment Study
Summary
Study start date: February 1, 2013
Actual date on which the first participant was enrolled.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 triggers from other sites such as left atrial posterior wall, superior vena cava, interatrial septum, crista terminalis, left atrial appendage and coronary sinus (1, 2). These are known to be independent predictors of late AF recurrence following catheter ablation (3, 4, and 5). Earlier studies have demonstrated better ablation outcome in NPAF when non-PV triggers sites were isolated along with PVAI (5, 6). Moreover, Verma et al had reported high (57%) recurrence rate post-index procedure in AF patients with pre-existent scar (7). However, published data are conflicting regarding the benefits of additional substrate guided ablation (scar homogenization) compared to conventional PVAI alone strategy (8). Also, 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, scar homogenization and ablation of extra-PV triggers has the highest likelihood of maintaining long-term sinus rhythm in patients with NPAF.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.186 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Texas Cardiac arrhythmia Institute, St. David's Hospital
Austin, United States