We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01672138
Recruitment Status : Active, not recruiting
First Posted : August 24, 2012
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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]


Condition or disease Intervention/treatment 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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Recurrence of atrial arrhythmia [ Time Frame: 3 years ]
    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 :
  1. Improvement in quality of life [ Time Frame: 3 years ]
    Improvement in quality of life


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672138


Locations
United States, Texas
St. david's medical Center
Austin, Texas, United States, 78705
Texas Cardiac arrhythmia Institute, St. David's Hospital
Austin, Texas, United States, 78705
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
California Pacific Medical Center
Investigators
Principal Investigator: Andrea Natale, MD TCAI
More Information

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
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: October 2016

Keywords provided by Andrea Natale, 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