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NCT00392054 · ClinicalTrials.gov registry record · Phase 3

First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)

A Phase 3 study, sponsored by Population Health Research Institute.

Completed
Registry status
Phase 3
Development phase
127
Enrollment target

NCT00392054: Completed Phase 3 study, sponsored by Population Health Research Institute.

NCT00392054 is a Phase 3 study that has completed, run by Population Health Research Institute. The registered enrollment target is 127 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00392054, a Phase 3 study, has completed, sponsored by Population Health Research Institute.

COMPLETED
Registry status
Phase 3
Development phase
127 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of antiarrhythmic drugs.

Primary Outcome

Recurrence of electrocardiographically documented atrial fibrillation, atrial flutter or atrial tachycardia lasting \>30 seconds during Follow-up Period. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).

Interventions

  • PROCEDURE Pulmonary Vein Isolation performed by Catheter Ablation
  • DRUG Conventional Antiarrhythmic Drug Therapy

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2006-08
Est. Completion 2012-02
Phase Phase 3

What the finished NCT00392054 record still lists

NCT00392054 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 2 interventions - of which Pulmonary Vein Isolation performed by Catheter Ablation is the first listed.

NCT00392054 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00392054 about?

NCT00392054 is a clinical study titled "First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)". The purpose of this study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of antiarrhythmic drugs.

What is the current status of trial NCT00392054?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 127 participants. The study started on 2006-08. Estimated completion is 2012-02.

What interventions are being tested in trial NCT00392054?

The interventions under investigation include: Pulmonary Vein Isolation performed by Catheter Ablation (PROCEDURE), Conventional Antiarrhythmic Drug Therapy (DRUG).

Who is sponsoring clinical trial NCT00392054?

This trial is sponsored by Population Health Research Institute, which has 21 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00392054's enrollment target sits among peer trials

127 1602nd of 2000 higher than 398 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00392054, the US trial registry maintained by the National Library of Medicine. NCT00392054 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.