Adjuvant Radiation in Aortic Valvuloplasty - ARAVA

This study has been terminated.
Sponsor:
Information provided by:
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT00269165
First received: December 22, 2005
Last updated: May 28, 2010
Last verified: May 2010
  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
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 Research Institute:

Estimated Enrollment: 60
Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269165

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

No publications provided

ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on July 22, 2014