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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00984204

Public ClinicalTrials.gov record NCT00984204. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 8:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT00984204
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Abbott Medical Devices
Industry
Enrollment
188 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2009 (Type not available)
Primary completion
Aug 2010 (Actual)
Completion
Jan 2012 (Actual)
Last update posted
Feb 19, 2019

2009 – 2012

United States locations

U.S. sites
20
U.S. states
13
U.S. cities
19
Facility City State ZIP Site status
Regional Cardiology Associates Sacramento California 95819 —
Kansas University Medical Center Kansas City Kansas 66160 —
Central Baptist Hospital Lexington Kentucky 40503 —
Ochsner Medical Center New Orleans Louisiana 70121 —
Washington Adventist Hospital Takoma Park Maryland 20912 —
Lahey Clinic Medical Center Burlington Massachusetts 01805 —
University of Rochester Rochester New York 14642 —
Carolinas Medical Center Charlotte North Carolina 28203 —
Moses Cone Hospital Greensboro North Carolina 27401 —
Ohio State Medical Columbus Ohio 43210 —
Cardiovascular Associates of Cleveland Mayfield Heights Ohio 44124 —
Providence St. Vincent Medical Center Portland Oregon 97225 —
Doylestown Hospital Doylestown Pennsylvania 18901 —
Main Line Health Center/Lankenau Wynnewood Pennsylvania 19096 —
Baylor Jack and Jane Hamilton Heart and Vascular Hospital Dallas Texas 75226 —
St. Luke's Episcopal Hospital Houston Texas 77030 —
The Methodist Hospital Houston Texas 77030 —
Scott & White Memorial Hospital Temple Texas 76508 —
Virginia Hospital Center Arlington Virginia 22205 —
University of Virginia Medical Center Charlottesville Virginia 22908 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00984204, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 19, 2019 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00984204 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →