Ten-year Outcomes After AF Ablation

December 13, 2014 updated by: Jonathan Steinberg,MD, Valley Health System

Long-term Outcome After Initially Successful Catheter Ablation of Atrial Fibrillation by Pulmonary Vein Isolation: a Ten-Year Cohort Study

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.

Study Overview

Status

Completed

Conditions

Atrial Fibrillation

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

445

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New Jersey
  - Ridgewood, New Jersey, United States, 07450
    - Valley Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent PVI ablation for drug refractory AF over a 10 year period and were free of AF for one year after last ablation procedure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Post-successful ablation Patients who had undergone PVI ablation for AF and were free of AF for at least one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Atrial fibrillation or flutter > 30 secs Time Frame: More than one year after successful primary ablation or redo procedure within 6 mos	More than one year after successful primary ablation or redo procedure within 6 mos

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valley Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria