Ten-year Outcomes After AF Ablation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867099
• Other study ID #: Valley 12.0032
• Status: Completed
• Phase: N/A
• First received: May 29, 2013
• Last updated: December 13, 2014
• Start date: December 2002
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: Valley Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	Valley Hospital	Ridgewood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Valley Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation or flutter > 30 secs		More than one year after successful primary ablation or redo procedure within 6 mos	No