Status:
COMPLETED
Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter
Lead Sponsor:
Abbott Medical Devices
Conditions:
Typical Atrial Flutter
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result ...
Detailed Description
This will be a prospective, multi-center and non-randomized study. All treated patients will receive ablation therapy for typical atrial flutter using the TherapyTM Cool FlexTM Irrigated Ablation Syst...
Eligibility Criteria
Inclusion
- A signed written Informed Consent
- Presence of typical atrial flutter (cavo-tricuspid isthmus dependent)
- If subjects are receiving anti-arrhythmic 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
- Clinically significant Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve
- Evidence of intra-cardiac thrombus or a history of clotting disorders
- Participation in another investigational study
- Cardiac surgery within 1 month prior to the intended procedure date
- Allergy or contraindication to Heparin
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01408485
Start Date
November 1 2011
End Date
October 1 2012
Last Update
February 15 2019
Active Locations (24)
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1
St. Joseph's Hospital-Heart Rhythm Specialists, PC
Phoenix, Arizona, United States, 85013
2
Summit - Cardiovascular Consultants Med Group, Inc.
Oakland, California, United States, 94609
3
Huntington Memorial / Foothill Cardiology
Pasadena, California, United States, 91105
4
Regional Cardiology Associates
Sacramento, California, United States, 95819