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Does Atrial Fibrillation (AF) Termination Without Additional Ablation Influence Outcome? (TARGET)

This study is currently recruiting participants.
Verified October 2016 by Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01696344
First Posted: October 1, 2012
Last Update Posted: April 27, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
California Pacific Medical Center
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
  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
Atrial Fibrillation Procedure: PVAI Procedure: PVAI + ablation of extraPV triggers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does AF Termination Without Additional Ablation Influence Outcome?

Resource links provided by NLM:


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

Primary Outcome Measures:
  • AF recurrence [ Time Frame: 3 years ]
    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: May 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Drug-refractory long-standing persistent atrial fibrillation
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. LSP-AF patients experiencing AF termination during ablation
  3. Ability to understand and provide signed informed consent

Exclusion Criteria:

  1. Previous left atrial 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): NCT01696344


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 PhD       dibbia@gmail.com   
Contact: Mitra Mohanty, MD MS       mitra1989@gmail.com   
Principal Investigator: Andrea Natale, MD         
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

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
First Submitted: September 27, 2012
First Posted: October 1, 2012
Last Update Posted: April 27, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrea Natale, 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