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Adjuvant Radiation in Aortic Valvuloplasty - ARAVA

This study has been terminated.
Information provided by:
Medstar Health Research Institute Identifier:
First received: December 22, 2005
Last updated: May 28, 2010
Last verified: May 2010
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.

Condition Intervention Phase
Aortic Valve Stenosis
Procedure: Balloon Aortic Valvuloplasty
Procedure: External Beam Radiation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Medstar Health Research Institute:

Estimated Enrollment: 60
Study Start Date: November 2005

Ages Eligible for Study:   75 Years and older   (Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00269165

Sponsors and Collaborators
Medstar Health Research Institute
Principal Investigator: Ron Waksman, MD Medstar Health Research Institute
  More Information Identifier: NCT00269165     History of Changes
Other Study ID Numbers: 2005-187 
Study First Received: December 22, 2005
Last Updated: May 28, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction processed this record on December 09, 2016