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Adjuvant Radiation in Aortic Valvuloplasty - ARAVA

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00269165
First Posted: December 23, 2005
Last Update Posted: May 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medstar Health Research Institute
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00269165     History of Changes
Other Study ID Numbers: 2005-187
First Submitted: December 22, 2005
First Posted: December 23, 2005
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