Safety and Efficacy of CryoCor™ Cryoablation for PAF
A Clinical Study to Evaluate the Safety and Efficacy of the CryoCor(TM)Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation
1 other identifier
interventional
174
1 country
24
Brief Summary
A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Nov 2004
Typical duration for not_applicable atrial-fibrillation
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedMay 4, 2017
May 1, 2017
4.3 years
September 30, 2005
May 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety profile of intervention
12 months
Recurrence of PAF
12 months
Secondary Outcomes (5)
Change in QOL as measured by SF-36 Health Survey
12 months
Change in QOL as measured by Symptom Checklist
12 months
Change in QOL as measured by Arrhythmia Severity scale
12 months
Change in luminal PV measurements
6 months
Time to treatment failure, post resolution period
Post resolution period (12 months follow-up)
Study Arms (2)
Treatment with CryoCor Cryoablation System
ACTIVE COMPARATORIntervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF.
Treatment with standard medical therapy
ACTIVE COMPARATORIntervention includes treatment with ant-arrhythmic medications alone.
Interventions
Treatment with CryoCor Cardiac Cryoablation system
Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications
Eligibility Criteria
You may qualify if:
- At least 3 episodes of PAF within 6 months
- Refractory to at least one drug
- Therapeutic anticoagulation
- Signed informed consent
You may not qualify if:
- Persistent AF
- Structural heart disease
- Prior ablation
- Contraindication present
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Regional Cardiology Associates
Sacramento, California, 95819, United States
UCSD Medical Center
San Diego, California, 92103, United States
UCSF Medical
San Francisco, California, 94143, United States
University of Florida
Gainesville, Florida, 32611, United States
University of South Florida
Tampa, Florida, 33606, United States
Emory University
Atlanta, Georgia, 30308, United States
University of Chicago Hospitals
Chicago, Illinois, 60637, United States
Carle Heart Center
Urbana, Illinois, 61801, United States
Genesis Health
Davenport, Iowa, 52803, United States
Iowa Heart Center
Des Moines, Iowa, 50309, United States
Cardiology Associates of Kentucky
Lexington, Kentucky, 40504, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Penn State Heart and Vascular Institute
Hershey, Pennsylvania, 17033, United States
Drexel University
Philadelphia, Pennsylvania, 19102, United States
Austin Heart, PA
Austin, Texas, 78756, United States
Methodist Debakey Heart Center
Houston, Texas, 77030, United States
Tacoma General
Tacoma, Washington, 98415, United States
Heart Care Associates
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Feld, MD
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
November 1, 2004
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
May 4, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share