Adjuvant Radiation in Aortic Valvuloplasty - ARAVA
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 23, 2005
CompletedMay 31, 2010
May 1, 2010
December 22, 2005
May 28, 2010
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ron Waksman, MD
Medstar Health Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 23, 2005
Study Start
November 1, 2005
Last Updated
May 31, 2010
Record last verified: 2010-05