Adjuvant Radiation in Aortic Valvuloplasty - ARAVA

MedStar Health

Status and phase: Terminated; Phase 3

Conditions: Aortic Valve Stenosis

Treatments: Procedure: External Beam Radiation; Procedure: Balloon Aortic Valvuloplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00269165

2005-187

Details and patient eligibility

About

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.

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind