Does Atrial Fibrillation (AF) Termination Without Additional Ablation Influence Outcome?
TARGET
Does AF Termination Without Additional Ablation Influence Outcome?
1 other identifier
observational
60
1 country
2
Brief Summary
This prospective study aims to investigate if termination of atrial fibrillation (AF) after pulmonary vein antrum isolation (PVAI) without additional ablation of non-PV triggers, in long-standing persistent (LSP) AF, is enough to ensure long-term success.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2012
Longer than P75 for all trials
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
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 27, 2012
CompletedFirst Posted
Study publicly available on registry
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 10, 2019
April 1, 2019
6.6 years
September 27, 2012
April 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AF recurrence
Any episode of AF/AT 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
Study Arms (2)
Cohort 1
No additional ablation after AF termination(PVAI only)
Cohort 2
Additional ablation of extra-PV triggers before and after isoproterenol-challenge after AF termination (PVAI + ablation of extra-PV triggers)
Interventions
PVAI followed by ablation of extra-PV triggers originating from sites other than pulmonary veins such as superior vena cava, ligament of Marshall, coronary sinus, crista terminalis, left atrial (LA) posterior wall and LA appendage
Eligibility Criteria
Drug-refractory long-standing persistent atrial fibrillation
You may qualify if:
- Age ≥ 18 years
- LSP-AF patients experiencing AF termination during ablation
- Ability to understand and provide signed informed consent
You may not qualify if:
- Previous left atrial 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Medical Director, TCAI
Study Record Dates
First Submitted
September 27, 2012
First Posted
October 1, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
April 10, 2019
Record last verified: 2019-04