Status:
COMPLETED
Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
Lead Sponsor:
Abbott Medical Devices
Conditions:
Typical Atrial Flutter
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 unaccepta...
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 ty...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00984204
Start Date
October 1 2009
End Date
January 1 2012
Last Update
February 19 2019
Active Locations (22)
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1
Regional Cardiology Associates
Sacramento, California, United States, 95819
2
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
3
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
4
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121