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Adjuvant Radiation in Aortic Valvuloplasty - ARAVA

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ClinicalTrials.gov Identifier: NCT00269165
Recruitment Status : Terminated
First Posted : December 23, 2005
Last Update Posted : May 31, 2010
Sponsor:
Information provided by:
Medstar Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Procedure: Balloon Aortic Valvuloplasty Procedure: External Beam Radiation Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : November 2005

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269165


Sponsors and Collaborators
Medstar Health Research Institute
Investigators
Principal Investigator: Ron Waksman, MD Medstar Health Research Institute

ClinicalTrials.gov Identifier: NCT00269165     History of Changes
Other Study ID Numbers: 2005-187
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: May 31, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction