Ten-year Outcomes After AF Ablation

NCT ID: NCT01867099

Last Updated: 2014-12-16

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

COMPLETED

Total Enrollment

445 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-12-31

Study Completion Date

2012-12-31

Brief Summary

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Ablation of atrial fibrillation (AF) using pulmonary vein isolation is employed when patients do not respond favorably to medical therapy. Successful procedures are accomplished in the majority of patients, but the outcome after many years of follow-up after ablation is unknown.

Detailed Description

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A prospectively identified cohort of 445 patients who demonstrated freedom from AF for at least one year following ablation (single procedure in 391, 87.9%) was followed for 66.0 ± 34.0 months. Patients were seen at least annually as outpatients, and underwent regular ECG monitoring, especially if there were symptoms suggestive of recurrent arrhythmia. Continued absence of arrhythmia was defined as freedom from AF or flutter \> 30 secs.

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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Post-successful ablation

Patients who had undergone PVI ablation for AF and were free of AF for at least one year

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Prior AF ablation procedure
* No AF for one year post ablation

Exclusion Criteria

* Geographic inaccessibility
* Longstanding persistent AF
* Recurrent AF within one year of ablation
* Prior AF ablation
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valley Health System

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Steinberg,MD

Director, Arrhythmia Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Valley Hospital

Ridgewood, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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Valley 12.0032

Identifier Type: -

Identifier Source: org_study_id