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NCT00984204 · ClinicalTrials.gov registry record · Phase 3

Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)

A Phase 3 study, sponsored by Abbott Medical Devices.

Completed
Registry status
Phase 3
Development phase
188
Enrollment target

NCT00984204: Completed Phase 3 study, sponsored by Abbott Medical Devices.

NCT00984204 is a Phase 3 study that has completed, run by Abbott Medical Devices. The registered enrollment target is 188 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00984204, a Phase 3 study, has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
Phase 3
Development phase
188 participants
Enrollment target

Study Summary

The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).

Interventions

  • DEVICE Therapy Cool Path Duo

Trial Details

FieldValue
Enrollment Target 188 participants
Start Date 2009-10
Est. Completion 2012-01
Phase Phase 3
Abbott Medical Devices

261 total trials

What the finished NCT00984204 record still lists

NCT00984204 is an interventional study that assigns participants to a tested intervention. The registered 188 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 (76% lower).

The record links to 0 conditions, and to 1 intervention - of which Therapy Cool Path Duo is the first listed.

NCT00984204 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00984204 about?

NCT00984204 is a clinical study titled "Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)". The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).

What is the current status of trial NCT00984204?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2009-10. Estimated completion is 2012-01.

What interventions are being tested in trial NCT00984204?

The interventions under investigation include: Therapy Cool Path Duo (DEVICE).

Who is sponsoring clinical trial NCT00984204?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00984204's enrollment target sits among peer trials

188 1408th of 2000 higher than 591 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 NCT00984204, the US trial registry maintained by the National Library of Medicine. NCT00984204 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.