Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
- Conditions
- Typical Atrial Flutter
- Interventions
- Device: Therapy Cool Path Duo
- Registration Number
- NCT00984204
- Lead Sponsor
- Abbott Medical Devices
- Brief 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).
- Detailed Description
This is a prospective, multi-center, non-randomized study (historical data as control) for the evaluating the safety and efficacy of Therapy TM Cool PathTM
Duo Ablation System for the treatment of typical atrial flutter (Cavo-triscupid isthmus dependent)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment arm Therapy Cool Path Duo -
- Primary Outcome Measures
Name Time Method Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness. 7 days Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained. 30 mins
- Secondary Outcome Measures
Name Time Method Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure 3 months
Trial Locations
- Locations (22)
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States
Lahey Clinic Medical Center
🇺🇸Burlington, Massachusetts, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
University of Rochester
🇺🇸Rochester, New York, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Main Line Health Center/Lankenau
🇺🇸Wynnewood, Pennsylvania, United States
Virginia Hospital Center
🇺🇸Arlington, Virginia, United States
Victoria Cardiac Arrhythmia Trials, Inc.
🇨🇦Victoria, British Columbia, Canada
Institut de Cardiologie de Quebec
🇨🇦Quebec, Canada
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, 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
St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Regional Cardiology Associates
🇺🇸Sacramento, California, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States