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

Primary Purpose

Atrial Flutter

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Catheter-based cardiac cryoablation
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Flutter focused on measuring atrial flutter, cryoablation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Symptomatic atrial flutter Exclusion Criteria: Prior ablation Contraindication to intervention Poor general health

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Acute efficacy
    Acute safety

    Secondary Outcome Measures

    Long-term efficacy
    Long-term safety

    Full Information

    First Posted
    June 6, 2005
    Last Updated
    February 23, 2011
    Sponsor
    Boston Scientific Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00113178
    Brief Title
    Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Boston Scientific Corporation

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Flutter
    Keywords
    atrial flutter, cryoablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    160 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Catheter-based cardiac cryoablation
    Primary Outcome Measure Information:
    Title
    Acute efficacy
    Title
    Acute safety
    Secondary Outcome Measure Information:
    Title
    Long-term efficacy
    Title
    Long-term safety

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Symptomatic atrial flutter Exclusion Criteria: Prior ablation Contraindication to intervention Poor general health

    12. IPD Sharing Statement

    Links:
    URL
    http://www.cryocor.com/
    Description
    Related Info

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

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