The objective of the RADAR trial is to determine the impact of External Beam Radiation Therapy (EBRT) on aortic valve restenosis following successful percutaneous balloon aortic valvuloplasty (BAV) in elderly patients with severe calcific aortic stenosis.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Lindner Clinical Trial Center
Cincinnati, Ohio, United States
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 Improvement
Improvement from pre-procedural NYHA class. Patients' heart failure were graded according to the severity of their symptoms. The New York Heart Association (NYHA) Functional Classification was used. It places patients in one of four categories based on how much they are limited during physical activity. I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). III Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Time frame: 6 months
CHF Rehospitalization
Time frame: 6 months
Aortic Valve Reintervention
Time frame: 6 months
Aortic Valve Area Late Loss Index
The difference between the Aortic Valve Area at 6 months and the Aortic Valve Area post procedure indexed to the subject
Time frame: 6 months
Aortic Valve Mean Gradient
Time frame: 6 months
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