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

September 30, 2005
July 14, 2011
November 2004
March 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Safety profile of intervention
  • Recurrence of symptomatic PAF
Complete list of historical versions of study NCT00231296 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
  • Device: Cardiac cryoablation system
    Treatment with CryoCor cardiac cryoablation system
  • Drug: Medical management
    Treatment with standard medical therapy
  • Active Comparator: 1
    Treatment with CryoCor Cryoablation System
    Intervention: Device: Cardiac cryoablation system
  • Active Comparator: 2
    Treatment with standard medical therapy
    Intervention: Drug: Medical management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00231296
GL-AF-02
No
Boston Scientific, Clinical Department, CryoCor, Inc.
Boston Scientific Corporation
Not Provided
Principal Investigator: Gregory Feld, MD University of California, San Diego (UCSD)
Boston Scientific Corporation
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP