Adjuvant Radiation in Aortic Valvuloplasty - ARAVA

Phase 3TerminatedNCT00269165

Medstar Health Research Institute60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Aortic Valve Stenosis

Interventions

Balloon Aortic ValvuloplastyPROCEDURE

External Beam RadiationPROCEDURE

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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