Does Atrial Fibrillation (AF) Termination Without Additional Ablation Influence Outcome? (TARGET)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Procedure: PVAI Procedure: PVAI + ablation of extraPV triggers |
Phase 3 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Does AF Termination Without Additional Ablation Influence Outcome? |
- AF recurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Cohort 1
No additional ablation after AF termination(PVAI only)
|
Procedure: PVAI
Other Name: Pulmonary vein antrum isolation
|
|
Cohort 2
Additional ablation of extra-PV triggers before and after isoproterenol-challenge after AF termination (PVAI + ablation of extra-PV triggers)
|
Procedure: PVAI + ablation of extraPV triggers
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
|
Detailed Description:
Background: AF is a heterogeneous arrhythmia. At its simplest, it is triggered by rapidly firing foci around pulmonary veins (PV) and can be cured by isolation of PV alone. Evidences suggest that when high frequency of atrial activation is maintained for relatively longer period (as in persistent or long-standing AF), ion channel remodeling changes the electrophysiologic substrate and lead to AF permanence. Therefore, PVAI alone, as anticipated, demonstrates to have limited success rate in persistent and LSP AF and additional ablations beyond PVAI involving substrate modification are advocated by many experts in electrophysiology. However, there is yet no consensus on the ablation strategy for long-standing AF. It is still not clear whether AF termination during ablation could be considered as an ablation endpoint or not, as earlier studies have reported results that are at variance with each other. Some studies have suggested that termination of AF during ablation is associated with reduced recurrence of arrhythmia while others detected no association of AF termination with long-term maintenance of sinus rhythm (SR) in persistent or LSP-AF.Therefore this study aims to examine ablation outcomes in LSP-AF patients with AF termination with or without additional ablation of extra-PV triggers.
Hypothesis: AF termination does not eliminate the need for additional ablations in achieving long-term ablation success in LSP-AF.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Drug-refractory long-standing persistent atrial fibrillation
Inclusion Criteria:
- Age ≥ 18 years
- LSP-AF patients experiencing AF termination during ablation
- Ability to understand and provide signed informed consent
Exclusion Criteria:
- Previous left atrial 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 PhD dibbia@gmail.com | |
| Contact: Mitra Mohanty, MD MS mitra1989@gmail.com | |
| Principal Investigator: Andrea Natale, MD | |
| 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: | NCT01696344 History of Changes |
| Other Study ID Numbers: | TCAI_TARGET |
| Study First Received: | September 27, 2012 |
| Last Updated: | September 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Texas Cardiac Arrhythmia Research Foundation:
|
LSPAF AF termination PVAI nonPV triggers Long-standing persistent |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013