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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.
ClinicalTrials.gov Identifier: NCT00231296
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Atrial Fibrillation Device: Cardiac CryoCor Cryoablation System Drug: Medical management

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 Design

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
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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.


Eligibility Criteria

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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00231296


  Show 24 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Gregory Feld, MD University of California, San Diego (UCSD)
More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov 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:
cryoablation
atrial fibrillation

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