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

Condition Intervention
Atrial Fibrillation
Device: Cardiac CryoCor Cryoablation System
Drug: Medical management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 ]
  • Recurrence of PAF [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • 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.


Enrollment: 174
Actual 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: 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

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   (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
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

  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
Study First Received: September 30, 2005
Last Updated: May 2, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on May 25, 2017