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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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 ] [ Designated as safety issue: Yes ]
  • Recurrence of PAF [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231296

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

No publications provided

Responsible Party: Boston Scientific, Clinical Department, CryoCor, Inc.
ClinicalTrials.gov Identifier: NCT00231296     History of Changes
Other Study ID Numbers: GL-AF-02
Study First Received: September 30, 2005
Last Updated: July 14, 2011
Health Authority: United States: Food and Drug Administration

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 April 17, 2014