Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis (RADAR)
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|ClinicalTrials.gov Identifier: NCT00538759|
Recruitment Status : Terminated (Funding shortfall)
First Posted : October 3, 2007
Last Update Posted : May 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis||Device: External beam radiation therapy||Phase 2 Phase 3|
The RADAR trial is a prospective, randomized, double-blind, sham-controlled, two-stage, adaptive clinical trial. Following successful Balloon Aortic Valvuloplasty, patients with severe aortic stenosis will be randomized in a 2:1 fashion to External Beam Radiation Therapy (EBRT) plus standard medical therapy or standard medical therapy along with sham EBRT (placebo). During Stage One, approximately 110 patients will be enrolled in order to have 80 patients randomized and 66 patients with valid 6 month data. The sample size for Stage Two will be calculated at the end of Stage One. At the time of study commencement, the expectation is that the total sample size will be approximately 155 patients with valid 6-month data, and thus 195 will be randomized and up to 250 enrolled.
Patients will be followed for a period of two (2) years. Echocardiographic and clinical endpoint data will be collected and analyzed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||RADiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis|
|Study Start Date :||September 2007|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.
Device: External beam radiation therapy
Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty
- Aortic valve area as a continuous variable, measured by echocardiography [ Time Frame: 6 months ]
- Incidence of major External Beam Radiation Therapy-related complications [ Time Frame: 6 months ]
- NYHA, CHF rehospitalization, aortic valve reintervention, aortic valve area late loss index, aortic valve mean gradient. [ Time Frame: 6 months ]
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): NCT00538759
|United States, Minnesota|
|Abbott Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55407|
|United States, Ohio|
|Lindner Clinical Trial Center|
|Cincinnatti, Ohio, United States, 45219|
|Principal Investigator:||Wes R Pedersen, MD||Minneapolis Heart Institute Foundation|