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| Sponsor: | Minneapolis Heart Institute Foundation |
|---|---|
| Collaborators: |
Twin Cities Heart Foundation Minneapolis Heart Institute |
| Information provided by: | Minneapolis Heart Institute Foundation |
| ClinicalTrials.gov Identifier: | NCT00538759 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Aortic Valve Stenosis |
Device: External beam radiation therapy |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | RADiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis |
| Estimated Enrollment: | 195 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
EBRT: Experimental
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
|
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.
Eligibility| Ages Eligible for Study: | 75 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Minneapolis Heart Institute ( Wes R Pedersen, MD Principal Investigator ) |
| Study ID Numbers: | G060198 |
| Study First Received: | October 1, 2007 |
| Last Updated: | June 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00538759 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Aortic valve stenosis Balloon aortic valvuloplasty Aortic valve restenosis |
|
Heart Diseases Cardiovascular Diseases Aortic Valve Stenosis Ventricular Outflow Obstruction Heart Valve Diseases |