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Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00113178
First received: June 6, 2005
Last updated: February 23, 2011
Last verified: February 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy of right atrial intra-cardiac lesions created by transvenous catheter cryoablation in patients with atrial flutter.


Condition Intervention Phase
Atrial Flutter
 Device: Catheter-based cardiac cryoablation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Cavo-Tricuspid Valve Isthmus-Dependent Atrial Flutter

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Acute efficacy
  • Acute safety

Secondary Outcome Measures:
  • Long-term efficacy
  • Long-term safety

Estimated Enrollment: 160
Study Start Date: January 2004
Study Completion Date: June 2005
Detailed Description:

Catheter ablation of arrhythmias has become an accepted alternative to pharmacologic therapy. Cryoablation is a newer alternative to radiofrequency ablations. This study expands the prior pilot experience with the CryoCor™ Cardiac Cryoablation System to a larger cohort of patients with atrial flutter.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic atrial flutter

Exclusion Criteria:

  • Prior ablation
  • Contraindication to intervention
  • Poor general health
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00113178     History of Changes
Other Study ID Numbers: GL-AFL-02
Study First Received: June 6, 2005
Last Updated: February 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
atrial flutter
cryoablation

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013