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...
Date First Received: December 22, 2005
Last Updated: August 2, 2006
Verified by: Medstar Research Institute, August 2006
Clinical Trial Phase: Phase 3 | Start Date: November 2005
Overall Status: Suspended
Estimated Enrollment: 60
Brief Summary
Condition Keyword(s):
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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 Sponsor Information
Lead Sponsor: Medstar Research Institute
Overall Clinical Trial Officials and Contacts
Ron Waksman, MD Principal Investigator Medstar Research Institute
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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
Clinical Trials Authorship and Review
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