Status:
COMPLETED
Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Lead Sponsor:
Abbott Medical Devices
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by documenting the procedural parameters, major complications and recurrence of AF after ablation using Cool Fle...
Eligibility Criteria
Inclusion
- A signed written Informed Consent form
- 18 years of age or older
- Agrees to comply with follow-up visits and evaluation
- Candidate for catheter ablation for the treatment of paroxysmal atrial fibrillation as per the hospital standard of care.
Exclusion
- Persistent or Long standing AF
- CABG procedure within the last 180 days (six months).
- Documented left atrial thrombus on imaging \[e.g. Transesophageal echocardiogram (TEE)\].
- History of blood clotting or bleeding abnormalities.
- Contraindication to anticoagulation (i.e. heparin or warfarin).
- Enrollment in another investigational study evaluating device or drug that might impact the results of this study.
- Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
- Acute illness or active systemic infection or sepsis.
- Life expectancy less than 12 months.
- Uncontrolled heart failure or NYHA class IV heart failure.
- Myocardial Infarction within 8 weeks of enrollment or unstable angina
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01185613
Start Date
June 1 2010
End Date
September 1 2011
Last Update
February 4 2019
Active Locations (6)
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1
Royal Adelaide Hospital
Adelaide, Australia
2
Hopital du Haut Leveque
Pessac, France
3
Universitat Leipzig Herzzentrum
Leipzig, Germany
4
Ospendale dell'Angelo
Mestre, Italy