Pulmonary Vein Antrum Isolation (PVAI) Plus Isolation of Complex Fractionated Atrial Electrograms (CAFE) and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation (TANTRA)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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]
| Condition | Intervention | Phase |
|---|---|---|
|
Persistent Atrial Fibrillation Long-standing Persistent Atrial Fibrillation |
Procedure: Pulmonary Vein Antrum Isolation Procedure: CFAE ablation Procedure: Isolation of non-PV triggers |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PVAI Plus Isolation of CAFEs and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation |
- Recurrence of atrial arrhythmia [ Time Frame: 3 years ] [ Designated as safety issue: No ]Any episode of AF/AT (atrial tachycardia) 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.
- Improvement in quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]Improvement in quality of life
| Estimated Enrollment: | 186 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Control
Pulmonary Vein Antrum Isolation alone
|
Procedure: Pulmonary Vein Antrum Isolation
Radio-frequency catheter ablation of pulmonary vein antrum
Other Name: PVAI
|
|
Active Comparator: Study I
PVAI+ CFAE ablation
|
Procedure: Pulmonary Vein Antrum Isolation
Radio-frequency catheter ablation of pulmonary vein antrum
Other Name: PVAI
Procedure: CFAE ablation
Catheter ablation of CFAEs
Other Name: CFAE
|
|
Active Comparator: Study II
PVAI + CFAE + non-PV triggers ablation
|
Procedure: Pulmonary Vein Antrum Isolation
Radio-frequency catheter ablation of pulmonary vein antrum
Other Name: PVAI
Procedure: CFAE ablation
Catheter ablation of CFAEs
Other Name: CFAE
Procedure: Isolation of non-PV triggers
Catheter ablation of triggers originating from extra-PV sites
Other Name: Non-PV triggers ablation
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 years
- Patients presenting with drug-refractory long-standing persistent AF (LSPAF)
- Ability to understand and provide signed informed consent
Exclusion Criteria:
- Previous catheter ablation or MAZE procedure in left atrium
- Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc
Contacts and Locations| Contact: Andrea Natale, MD | dr.natale@gmail.com | |
| Contact: Luigi Di Biase, MD PhD | dibbia@gmail.com |
| United States, Texas | |
| St. david's medical Center | Not yet recruiting |
| Austin, Texas, United States, 78705 | |
| Contact: Luigi Di Biase, MD dibbia@gmail.com | |
| Contact: Mitra Mohanty, MD mitra1989@gmail.com | |
| Principal Investigator: | Andrea Natale, MD | TCAI |
More Information
No publications provided
| Responsible Party: | Andrea Natale, Executive medical director, TCAI, Texas Cardiac Arrhythmia Research Foundation |
| ClinicalTrials.gov Identifier: | NCT01672138 History of Changes |
| Other Study ID Numbers: | TANTRA_TCAI |
| Study First Received: | August 21, 2012 |
| Last Updated: | August 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Texas Cardiac Arrhythmia Research Foundation:
|
PVAI CFAE NPAF |
Additional relevant MeSH terms:
|
Atrial Fibrillation Recurrence Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Disease Attributes |
ClinicalTrials.gov processed this record on May 19, 2013