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
  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
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

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 October 19, 2014