Adjuvant Radiation in Aortic Valvuloplasty - ARAVA
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...
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Procedure: Balloon Aortic Valvuloplasty
- Procedure: External Beam Radiation
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 75 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Medstar Research Institute Other
Overall Clinical Trial Officials and Contacts
Ron Waksman, MD Principal Investigator Medstar Research Institute
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00269165
Study ID Number: 2005-187
ClinicalTrials.gov Identifier: NCT00269165
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00269165
