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Safety and Efficacy of CryoCor™ Cryoablation for PAF

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

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00231296

  Show 23 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Gregory Feld, MD University of California, San Diego (UCSD)
  More Information

Additional Information:
Responsible Party: Boston Scientific Corporation Identifier: NCT00231296     History of Changes
Other Study ID Numbers: GL-AF-02
Study First Received: September 30, 2005
Last Updated: February 2, 2017

Keywords provided by Boston Scientific Corporation:
atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on March 24, 2017