NCT01867099

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
445

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2013

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

10 years

First QC Date

May 29, 2013

Last Update Submit

December 13, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation or flutter > 30 secs

    More than one year after successful primary ablation or redo procedure within 6 mos

Study Arms (1)

Post-successful ablation

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Geographic inaccessibility
  • Longstanding persistent AF
  • Recurrent AF within one year of ablation
  • Prior AF ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Arrhythmia Institute

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 3, 2013

Study Start

December 1, 2002

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations