Safety and Efficacy of CryoCor™ Cryoablation for PAF

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00231296
First received: September 30, 2005
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Atrial Fibrillation
Device: Cardiac cryoablation system
Drug: Medical management
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Safety profile of intervention [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Recurrence of PAF [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 174
Study Start Date: November 2004
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Treatment with CryoCor Cryoablation System
Device: Cardiac cryoablation system
Treatment with CryoCor cardiac cryoablation system
Active Comparator: 2
Treatment with standard medical therapy
Drug: Medical management
Treatment with standard medical therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231296

  Hide Study Locations
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 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
Baylor College of Medicine
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
Investigators
Principal Investigator: Gregory Feld, MD University of California, San Diego (UCSD)
  More Information

No publications provided

Responsible Party: Boston Scientific, Clinical Department, CryoCor, Inc.
ClinicalTrials.gov Identifier: NCT00231296     History of Changes
Other Study ID Numbers: GL-AF-02
Study First Received: September 30, 2005
Last Updated: July 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
cryoablation
atrial fibrillation

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

ClinicalTrials.gov processed this record on August 28, 2014