Adjuvant Radiation in Aortic Valvuloplasty - ARAVA

NCT ID: NCT00269165

Last Updated: 2010-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Balloon Aortic Valvuloplasty

Intervention Type PROCEDURE

External Beam Radiation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Principal Investigators

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Ron Waksman, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Countries

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United States

Other Identifiers

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2005-187

Identifier Type: -

Identifier Source: org_study_id