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

Completed · Phase 3

Conditions studied: Typical Atrial Flutter

In brief

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).

Key facts

Study ID

NCT00984204

Run by

Abbott Medical Devices

People needed

188

Starts

2009-10-01

Expected to finish

2012-01-01

Last updated by the study team

2019-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A signed written Informed Consent
• Presence of typical atrial flutter (cavotricuspid isthmus dependent)
• If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD)for an arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply.
• One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months
• In good physical health
• 18 years of age or older
• Agree to comply with follow-up visits and evaluation

You may not qualify if…

• Prior typical atrial flutter ablation treatment
• Pregnancy
• Atypical flutter or scar flutter(non-isthmus dependent)
• Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of enrollment
• A recent myocardial infarction within 3 months of the intended procedure date
• Permanent coronary sinus pacing lead
• Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve (i.e. significant)
• Evidence of intracardiac thrombus or a history of clotting disorders
• Participation in another investigational study
• Cardiac surgery within 1 month of the intended procedure date
• Allergy or contraindication to Heparin

Where it is running

• Regional Cardiology Associates — Sacramento, California, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Central Baptist Hospital — Lexington, Kentucky, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• University of Rochester — Rochester, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Moses Cone Hospital — Greensboro, North Carolina, United States
• Ohio State Medical — Columbus, Ohio, United States
• Cardiovascular Associates of Cleveland — Mayfield Heights, Ohio, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• Doylestown Hospital — Doylestown, Pennsylvania, United States
• Main Line Health Center/Lankenau — Wynnewood, Pennsylvania, United States
• Baylor Jack and Jane Hamilton Heart and Vascular Hospital — Dallas, Texas, United States
• St. Luke's Episcopal Hospital — Houston, Texas, United States
• The Methodist Hospital — Houston, Texas, United States
• Scott & White Memorial Hospital — Temple, Texas, United States
• Virginia Hospital Center — Arlington, Virginia, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States
• Victoria Cardiac Arrhythmia Trials, Inc. — Victoria, British Columbia, Canada
• Institut de Cardiologie de Quebec — Québec, Canada

Full record on ClinicalTrials.gov

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