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

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ClinicalTrials.gov Identifier: NCT00113178
Recruitment Status : Completed
First Posted : June 7, 2005
Last Update Posted : February 24, 2011
Sponsor:
Information provided by:
Boston Scientific Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Flutter Device: Catheter-based cardiac cryoablation Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
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
Study Start Date : January 2004
Actual Study Completion Date : June 2005



Primary Outcome Measures :
  1. Acute efficacy
  2. Acute safety

Secondary Outcome Measures :
  1. Long-term efficacy
  2. Long-term safety


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Additional Information:
ClinicalTrials.gov Identifier: NCT00113178     History of Changes
Other Study ID Numbers: GL-AFL-02
First Posted: June 7, 2005    Key Record Dates
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