Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis
Summary
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.
Description
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 Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Aortic Valve Stenosis
Intervention
External beam radiation therapy
Location
Abbott Northwestern Hospital
Minneapolis
Minnesota
United States
55407
Status
Active, not recruiting
Source
Minneapolis Heart Institute Foundation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00538759
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Aortic Valve Stenosis
A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
Discrete Subaortic Stenosis
A type of constriction that is caused by the presence of a fibrous ring (discrete type) below the AORTIC VALVE, anywhere between the aortic valve and the MITRAL VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
Aortic Stenosis, Supravalvular
A pathological constriction occurring in the region above the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
Aortic Stenosis, Subvalvular
A pathological constriction occurring in the region below the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
Aortic Valve Prolapse
The downward displacement of the cuspal or pointed end of the trileaflet AORTIC VALVE causing misalignment of the cusps. Severe valve distortion can cause leakage and allow the backflow of blood from the ASCENDING AORTA back into the LEFT VENTRICLE, leading to aortic regurgitation.
Clinical Trials
Adjuvant Radiation in Aortic Valvuloplasty - ARAVA
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 stenos...
Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement
Prospective, two academic center, non-randomized pilot, acute in-patient study correlating pre-operative imaging studies, intra-operative measurements and intra-operative balloon aortic va...
Statin Therapy in Asymptomatic Aortic Stenosis
There is evidence that the degenerative changes leading to aortic stenosis are caused by a chronic inflammatory process. Furthermore the development of aortic stenosis is partially depende...
The Effect of Lipitor on Aortic Stenosis
The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patien...
Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease
We sought to determine whether the dual-source computed tomography assessment of aortic valve stenosis and coronary artery disease is equivalent to or even better than conventional invasiv...
PubMed Articles
High-risk patients with aortic valve stenosis : Interventional therapy.
Aortic valve stenosis is the most prevalent, clinically significant valvular disorder in adult patients. Surgical valve replacement is the standard therapy for patients with symptomatic and severe aor...
Transcatheter aortic-valve replacement for inoperable severe aortic stenosis.
Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patien...
Aortic valve replacement for aortic stenosis caused by alkaptonuria.
We report a case of aortic stenosis associated with ochronosis in a 70-year-old man who underwent biologic aortic valve replacement. Intraoperative findings included ochronosis of a severely calcified...
Percutaneous aortic valve in severe valvular regurgitation caused by infective endocarditis.
Recently, the feasibility and safety of percutaneous aortic valve replacement (PAVR) have been reported in the treatment of degenerative aortic valve stenosis in patients at high-risk for surgical aor...
Surgical treatment of aortic valve disease.
The development of intraoperative transoesophageal echocardiography together with improved understanding of the functional anatomy of the aortic valve have allowed the design of several new conservati...
