Safety and Efficacy of CryoCor™ Cryoablation for PAF
- Conditions
- Atrial Fibrillation
- Interventions
- Drug: Medical managementDevice: Cardiac CryoCor Cryoablation System
- Registration Number
- NCT00231296
- Lead Sponsor
- Boston Scientific Corporation
- 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 fibrillation (PAF) in comparison to treatment with anti-arrhythmic medications alone. This study also evaluates the safety profile of the CryoCor(TM) Cardiac Cryoablation System when used in this same setting.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
- At least 3 episodes of PAF within 6 months
- Refractory to at least one drug
- Therapeutic anticoagulation
- Signed informed consent
- Persistent AF
- Structural heart disease
- Prior ablation
- Contraindication present
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment with standard medical therapy Medical management Intervention includes treatment with ant-arrhythmic medications alone. Treatment with CryoCor Cryoablation System Cardiac CryoCor Cryoablation System Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF.
- Primary Outcome Measures
Name Time Method Safety profile of intervention 12 months Recurrence of PAF 12 months
- Secondary Outcome Measures
Name Time Method Change in QOL as measured by Symptom Checklist 12 months Changes compared to baseline will be measured over a period of 12 months
Change in QOL as measured by SF-36 Health Survey 12 months Changes compared to baseline will be measured over a period of 12 months
Change in QOL as measured by Arrhythmia Severity scale 12 months Changes compared to baseline will be measured over a period of 12 months
Change in luminal PV measurements 6 months Time to treatment failure, post resolution period Post resolution period (12 months follow-up) Time to treatment failure, defined as event monitor documented recurrent atrial fibrillation, post resolution period.
Trial Locations
- Locations (24)
Emory University
🇺🇸Atlanta, Georgia, United States
Methodist Debakey Heart Center
🇺🇸Houston, Texas, United States
University of Chicago Hospitals
🇺🇸Chicago, Illinois, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
UCSF Medical
🇺🇸San Francisco, California, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Englewood Hospital and Medical Center
🇺🇸Englewood, New Jersey, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Regional Cardiology Associates
🇺🇸Sacramento, California, United States
UCSD Medical Center
🇺🇸San Diego, California, United States
St. Luke's-Roosevelt Hospital Center
🇺🇸New York, New York, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Heart Care Associates
🇺🇸Milwaukee, Wisconsin, United States
Austin Heart, PA
🇺🇸Austin, Texas, United States
Tacoma General
🇺🇸Tacoma, Washington, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Carle Heart Center
🇺🇸Urbana, Illinois, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
Penn State Heart and Vascular Institute
🇺🇸Hershey, Pennsylvania, United States
Cardiology Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Genesis Health
🇺🇸Davenport, Iowa, United States