Pulmonary Vein Antrum Isolation (PVAI) Plus Scar Homogenization and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation
TANTRA
PVAI Plus Scar Homogenization and Ablation of Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation
1 other identifier
interventional
186
1 country
2
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 : (i) pulmonary vein antrum isolation (PVAI) + isolation of left atrial posterior wall, (ii) PVAI plus scar homogenization, (iii) PVAI plus isolation of posterior wall plus ablation of non-PV triggers \[ PVAI: Pulmonary Vein Antrum Isolation Non-PV triggers: Triggers arising from sites other than pulmonary veins\]
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2012
CompletedFirst Posted
Study publicly available on registry
August 24, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedNovember 16, 2018
November 1, 2018
6.8 years
August 21, 2012
November 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence of atrial arrhythmia
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.
3 years
Secondary Outcomes (1)
Improvement in quality of life
3 years
Study Arms (3)
Control
ACTIVE COMPARATORPulmonary Vein Antrum Isolation (PVAI) + isolation of left atrial posterior wall
Study I
ACTIVE COMPARATORPVAI+ scar homogenization
Study II
ACTIVE COMPARATORPVAI + isolation of left atrial posterior wall + non-PV triggers ablation
Interventions
Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall
PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.
PVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Patients undergoing first catheter ablation for drug-refractory Persistent (PerAF) or long-standing persistent AF (LSPAF)
- Ability to understand and provide signed informed consent
You may not qualify if:
- Previous catheter ablation or MAZE procedure in left atrium
- Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
St. david's medical Center
Austin, Texas, 78705, United States
Texas Cardiac arrhythmia Institute, St. David's Hospital
Austin, Texas, 78705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Natale, MD
TCAI
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive medical director, TCAI
Study Record Dates
First Submitted
August 21, 2012
First Posted
August 24, 2012
Study Start
February 1, 2013
Primary Completion
December 1, 2019
Study Completion
December 1, 2020
Last Updated
November 16, 2018
Record last verified: 2018-11