Adjuvant Radiation in Aortic Valvuloplasty - ARAVA
This study has been terminated.
Sponsor:
Medstar Research Institute
Information provided by:
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT00269165
First received: December 22, 2005
Last updated: May 28, 2010
Last verified: May 2010
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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:
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 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 October 16, 2012
