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

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ClinicalTrials.gov Identifier: NCT01696344
Recruitment Status : Active, not recruiting
First Posted : October 1, 2012
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
California Pacific Medical Center
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Procedure: PVAI Procedure: PVAI + ablation of extraPV triggers

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.


Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does AF Termination Without Additional Ablation Influence Outcome?
Study Start Date : May 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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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

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


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

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 Posted: October 1, 2012    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
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