Safety and Efficacy of CryoCor™ Cryoablation for PAF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00231296
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : May 4, 2017
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Cardiac CryoCor Cryoablation System Drug: Medical management Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study to Evaluate the Safety and Efficacy of the CryoCor(TM)Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation
Actual Study Start Date : November 2004
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Treatment with CryoCor Cryoablation System
Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF.
Device: Cardiac CryoCor Cryoablation System
Treatment with CryoCor Cardiac Cryoablation system
Other Name: Ablation with the CryoCor ablation catheter
Active Comparator: Treatment with standard medical therapy
Intervention includes treatment with ant-arrhythmic medications alone.
Drug: Medical management
Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications
Other Name: AAD treatment

Primary Outcome Measures :
  1. Safety profile of intervention [ Time Frame: 12 months ]
  2. Recurrence of PAF [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change in QOL as measured by SF-36 Health Survey [ Time Frame: 12 months ]
    Changes compared to baseline will be measured over a period of 12 months

  2. Change in QOL as measured by Symptom Checklist [ Time Frame: 12 months ]
    Changes compared to baseline will be measured over a period of 12 months

  3. Change in QOL as measured by Arrhythmia Severity scale [ Time Frame: 12 months ]
    Changes compared to baseline will be measured over a period of 12 months

  4. Change in luminal PV measurements [ Time Frame: 6 months ]
  5. Time to treatment failure, post resolution period [ Time Frame: Post resolution period (12 months follow-up) ]
    Time to treatment failure, defined as event monitor documented recurrent atrial fibrillation, post resolution period.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 3 episodes of PAF within 6 months
  • Refractory to at least one drug
  • Therapeutic anticoagulation
  • Signed informed consent

Exclusion Criteria:

  • Persistent AF
  • Structural heart disease
  • Prior ablation
  • Contraindication present

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00231296

  Hide Study Locations
United States, California
Regional Cardiology Associates
Sacramento, California, United States, 95819
UCSD Medical Center
San Diego, California, United States, 92103
UCSF Medical
San Francisco, California, United States, 94143
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
University of South Florida
Tampa, Florida, United States, 33606
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30308
United States, Illinois
University of Chicago Hospitals
Chicago, Illinois, United States, 60637
Carle Heart Center
Urbana, Illinois, United States, 61801
United States, Iowa
Genesis Health
Davenport, Iowa, United States, 52803
Iowa Heart Center
Des Moines, Iowa, United States, 50309
United States, Kentucky
Cardiology Associates of Kentucky
Lexington, Kentucky, United States, 40504
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
United States, New York
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Heart and Vascular Institute
Hershey, Pennsylvania, United States, 17033
Drexel University
Philadelphia, Pennsylvania, United States, 19102
United States, Texas
Austin Heart, PA
Austin, Texas, United States, 78756
Methodist Debakey Heart Center
Houston, Texas, United States, 77030
United States, Washington
Tacoma General
Tacoma, Washington, United States, 98415
United States, Wisconsin
Heart Care Associates
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Gregory Feld, MD University of California, San Diego (UCSD)

Responsible Party: Boston Scientific Corporation Identifier: NCT00231296     History of Changes
Other Study ID Numbers: GL-AF-02
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Boston Scientific Corporation:
atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes