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Safety and Efficacy of CryoCor™ Cryoablation for PAF

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00231296
First received: September 30, 2005
Last updated: May 2, 2017
Last verified: May 2017

September 30, 2005
May 2, 2017
November 2004
March 2009   (Final data collection date for primary outcome measure)
  • Safety profile of intervention [ Time Frame: 12 months ]
  • Recurrence of PAF [ Time Frame: 12 months ]
  • Recurrence of symptomatic PAF
  • Safety profile of intervention
Complete list of historical versions of study NCT00231296 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
  • Change in luminal PV measurements [ Time Frame: 6 months ]
  • 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.
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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Atrial Fibrillation
  • Device: Cardiac CryoCor Cryoablation System
    Treatment with CryoCor Cardiac Cryoablation system
    Other Name: Ablation with the CryoCor ablation catheter
  • Drug: Medical management
    Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications
    Other Name: AAD treatment
  • Active Comparator: Treatment with CryoCor Cryoablation System
    Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF.
    Intervention: Device: Cardiac CryoCor Cryoablation System
  • Active Comparator: Treatment with standard medical therapy
    Intervention includes treatment with ant-arrhythmic medications alone.
    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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00231296
GL-AF-02
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
No
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Gregory Feld, MD University of California, San Diego (UCSD)
Boston Scientific Corporation
May 2017

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