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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:
ClinicalTrials.gov Identifier:
NCT00113178
First Posted: June 7, 2005
Last Update Posted: February 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boston Scientific Corporation
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Additional Information:
ClinicalTrials.gov Identifier: NCT00113178     History of Changes
Other Study ID Numbers: GL-AFL-02
First Submitted: June 6, 2005
First Posted: June 7, 2005
Last Update Posted: February 24, 2011
Last Verified: February 2011

Keywords provided by Boston Scientific Corporation:
atrial flutter
cryoablation

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