Status:
COMPLETED
Safety and Efficacy of CryoCor™ Cryoablation for PAF
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF
Detailed Description
The purpose of this prospective, randomized multi-center clinical study is to establish the benefits of the CryoCor(TM) Cardiac Cryoablation System for treating symptomatic paroxysmal atrial fibrillat...
Eligibility Criteria
Inclusion
- At least 3 episodes of PAF within 6 months
- Refractory to at least one drug
- Therapeutic anticoagulation
- Signed informed consent
Exclusion
- Persistent AF
- Structural heart disease
- Prior ablation
- Contraindication present
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00231296
Start Date
November 1 2004
End Date
March 1 2009
Last Update
May 4 2017
Active Locations (24)
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1
Regional Cardiology Associates
Sacramento, California, United States, 95819
2
UCSD Medical Center
San Diego, California, United States, 92103
3
UCSF Medical
San Francisco, California, United States, 94143
4
University of Florida
Gainesville, Florida, United States, 32611