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

This study has been completed.
Information provided by:
Boston Scientific Corporation Identifier:
First received: June 6, 2005
Last updated: February 23, 2011
Last verified: February 2011
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: 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.

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

Inclusion Criteria:

  • Symptomatic atrial flutter

Exclusion Criteria:

  • Prior ablation
  • Contraindication to intervention
  • Poor general health
  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.

No Contacts or Locations Provided
  More Information

Additional Information: Identifier: NCT00113178     History of Changes
Other Study ID Numbers: GL-AFL-02
Study First Received: June 6, 2005
Last Updated: February 23, 2011

Keywords provided by Boston Scientific Corporation:
atrial flutter

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on May 25, 2017