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Ten-year Outcomes After AF Ablation

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867099
Recruitment Status : Completed
First Posted : June 3, 2013
Last Update Posted : December 16, 2014
Sponsor:
Information provided by (Responsible Party):
Jonathan Steinberg,MD, Valley Health System

Brief Summary:
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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 445 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Long-term Outcome After Initially Successful Catheter Ablation of Atrial Fibrillation by Pulmonary Vein Isolation: a Ten-Year Cohort Study
Study Start Date : December 2002
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Atrial fibrillation or flutter > 30 secs [ Time Frame: More than one year after successful primary ablation or redo procedure within 6 mos ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

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): NCT01867099


Locations
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United States, New Jersey
Valley Hospital
Ridgewood, New Jersey, United States, 07450
Sponsors and Collaborators
Valley Health System
Additional Information:

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Responsible Party: Jonathan Steinberg,MD, Director, Arrhythmia Institute, Valley Health System
ClinicalTrials.gov Identifier: NCT01867099    
Other Study ID Numbers: Valley 12.0032
First Posted: June 3, 2013    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes