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Clinical Trials/NCT00113178
NCT00113178CompletedPhase 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 enrollmentStarted: January 1, 2004Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
160
Primary Endpoint
Acute efficacy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Industry

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