Adjuvant Radiation in Aortic Valvuloplasty - ARAVA

This study has been suspended.

First Received: December 22, 2005 Last Updated: August 2, 2006 History of Changes

Sponsored by:	Medstar Research Institute
Information provided by:	Medstar Research Institute
ClinicalTrials.gov Identifier:	NCT00269165

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 III

MedlinePlus related topics: Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

Study ID Numbers:	2005-187
Study First Received:	December 22, 2005
Last Updated:	August 2, 2006
ClinicalTrials.gov Identifier:	NCT00269165 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Diseases
Leflunomide
Adjuvants, Immunologic

Constriction, Pathologic
Aortic Valve Stenosis
Heart Valve Diseases

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Diseases
Aortic Valve Stenosis
Ventricular Outflow Obstruction
Heart Valve Diseases

ClinicalTrials.gov processed this record on May 06, 2009