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

NCT ID: NCT01696344

Last Updated: 2019-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

No additional ablation after AF termination(PVAI only)

PVAI

Intervention Type PROCEDURE

Cohort 2

Additional ablation of extra-PV triggers before and after isoproterenol-challenge after AF termination (PVAI + ablation of extra-PV triggers)

PVAI + ablation of extraPV triggers

Intervention Type PROCEDURE

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

Interventions

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PVAI

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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Pulmonary vein antrum isolation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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California Pacific Medical Center

OTHER

Sponsor Role collaborator

Texas Cardiac Arrhythmia Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Andrea Natale

Executive Medical Director, TCAI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Natale, MD

Role: PRINCIPAL_INVESTIGATOR

TCAI

Locations

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St. david's Medical Center

Austin, Texas, United States

Site Status

Texas Cardiac arrhythmia Institute, St. David's Hospital

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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TCAI_TARGET

Identifier Type: -

Identifier Source: org_study_id

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