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CompletedNCT01867099Updated Dec 16, 2014

Ten-year Outcomes After AF Ablation

An observational study in Atrial Fibrillation, sponsored by Valley Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-12-16.

Sponsored by Valley Health System · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
445
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 445 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Valley Health System is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
445 participants (actual)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Post-successful ablation

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

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What researchers measure

Primary outcomes

  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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Study locations

1 site
  • Valley Hospital
    Ridgewood, New Jersey 07450, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01867099
Lead sponsor
Valley Health System
Responsible party
Jonathan Steinberg,MD (Director, Arrhythmia Institute, Valley Health System) — Principal investigator
First posted
Jun 3, 2013
Start date
Dec 2002
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Dec 16, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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