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Adjuvant Radiation in Aortic Valvuloplasty - ARAVA

Primary Purpose

Aortic Valve Stenosis

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Balloon Aortic Valvuloplasty
External Beam Radiation
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

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

Inclusion Criteria: Severe Aortic Stenosis NYHA Class 2-4 CHF Symptoms Age > 75 EuroSCORE > 7 Prohibitively High Risk for Aortic Valve Replacement Surgery as Designated by a Cardiac Surgeon

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2005
    Last Updated
    May 28, 2010
    Sponsor
    Medstar Health Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00269165
    Brief Title
    Adjuvant Radiation in Aortic Valvuloplasty - ARAVA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2010
    Overall Recruitment Status
    Terminated
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Medstar Health Research Institute

    4. Oversight

    5. Study Description

    Brief Summary
    This study will examine the effect of external beam radiation therapy in the prevention of restenosis following successful balloon aortic valvuloplasty in severe, symptomatic aortic stenosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Valve Stenosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    60 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Balloon Aortic Valvuloplasty
    Intervention Type
    Procedure
    Intervention Name(s)
    External Beam Radiation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Severe Aortic Stenosis NYHA Class 2-4 CHF Symptoms Age > 75 EuroSCORE > 7 Prohibitively High Risk for Aortic Valve Replacement Surgery as Designated by a Cardiac Surgeon
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ron Waksman, MD
    Organizational Affiliation
    Medstar Health Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Adjuvant Radiation in Aortic Valvuloplasty - ARAVA

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