Status:
COMPLETED
Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System
Lead Sponsor:
Abbott Medical Devices
Conditions:
Typical Atrial Flutter
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter * Does not result i...
Detailed Description
This will be a prospective, multi-center and non-randomized study. All enrolled patients who meet the eligibility criteria will receive ablation therapy for typical atrial flutter using the Contact Th...
Eligibility Criteria
Inclusion
- A signed written Informed Consent
- Presence of typical atrial flutter (cavo-tricuspid isthmus dependent)
- If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then they need to be controlled on their medication for at least 3 months. If a 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 intracardiac 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 :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01401361
Start Date
October 1 2011
End Date
September 1 2012
Last Update
February 15 2019
Active Locations (20)
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1
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
2
Aurora Denver Cardiology
Denver, Colorado, United States, 80012
3
Hartford Hospital
Hartford, Connecticut, United States, 06102
4
St. Vincent's Hospital
Jacksonville, Florida, United States, 32204