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Clinical Trials/NCT00113178
NCT00113178
Completed
Phase 3

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

Boston Scientific Corporation0 sites160 target enrollmentJanuary 2004
ConditionsAtrial Flutter

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Atrial Flutter
Sponsor
Boston Scientific Corporation
Enrollment
160
Primary Endpoint
Acute efficacy
Status
Completed
Last Updated
15 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2004
End Date
June 2005
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Symptomatic atrial flutter

Exclusion Criteria

  • Prior ablation
  • Contraindication to intervention
  • Poor general health

Outcomes

Primary Outcomes

Acute efficacy

Acute safety

Secondary Outcomes

  • Long-term efficacy
  • Long-term safety

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