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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Texas Cardiac Arrhythmia Research Foundation
Sponsor:
Collaborator:
California Pacific Medical Center
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01672138
First received: August 21, 2012
Last updated: June 4, 2013
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: February 2013
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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672138

Contacts
Contact: Andrea Natale, MD dr.natale@gmail.com
Contact: Luigi Di Biase, MD PhD dibbia@gmail.com

Locations
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   
Texas Cardiac arrhythmia Institute, St. David's Hospital Recruiting
Austin, Texas, United States, 78705
Contact: Andrea Natale, MD    512-544-8186    dr.natale@gmail.com   
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
California Pacific Medical Center
Investigators
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: June 4, 2013
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 August 18, 2014