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| ID | Type | Description | Link |
|---|---|---|---|
| 13-H-0168 |
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| Name | Class |
|---|---|
| Medstar Health Research Institute | OTHER |
Background:
- Aortic valve stenosis is a disease that makes a major heart valve get smaller. This reduces heart function and causes death. Severe aortic stenosis (AS) can be treated in a couple of ways, including replacing a heart valve.
Objectives:
Researchers want to study fibrosis in the heart. A sub-study will test whether heart function and blood supply improve after a valve replacement.
Eligibility:
- Adults at least 18 years old with aortic stenosis.
Design:
Aortic valve stenosis is a disease that causes narrowing of a major heart valve, and that reduces heart function and causes death. The purpose of this protocol is to use magnetic resonance imaging of the heart to identify which patients would benefit from replacement of the diseased valve.
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the ability of cardiac MRI measurement of extracellular volume fraction (related to myocardial fibrosis) to predict short and long term LV function of subjects with severe aortic stenosis undergoing transcatheter AVR. | 3 years |
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Subjects must meet all the following inclusion criteria prior to enrollment into the trial:
Severe aortic stenosis defined as aortic valve area of less than 1 cm(2) or index area of 0.6 cm(2)/m(2) by echocardiography.
Symptomatic patients with aortic stenosis referred for medically indicated AVR
LV EF less than or equal to 0.50
Signed informed consent to participate in the study.
Specific criteria for MR perfusion sub-study:
Absence of any significant coronary lesions or presence of coronary disease for conservative (medical) therapy<TAB>.
EXCLUSION CRITERIA:
Inability to sign written informed consent.
Subjects with contraindication to MRI scanning, including the following devices or conditions:
Subjects with a known hypersensitivity, allergy or contraindication to iodine or gadolinium
Impaired renal excretory function, calculated as Glomerular Filtration Rate (GFR) <30mL/min/1.73m(2).
Contraindications for intravenous adenosine infusion:
Presence of any coexisting severe valvular disorder.
Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).
Need for emergency surgery for any reason.
Any case in which the practicing physician asserts that enrollment in the protocol will adversely affect the patient treatment course.
Specific exclusion criteria for MR perfusion sub-study:
No detectable reversible ischemia on pre-treatment/procedure cardiac MRI.
Subject underwent transcatheter AVR as part of one of the transcatheter heart valve trials (i.e. PARTNER trial or the pivotal CoreValve trial).
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| Name | Affiliation | Role |
|---|---|---|
| Andrew E Arai, M.D. | National Heart, Lung, and Blood Institute (NHLBI) | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22443479 | Background | Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26. | |
| 22443478 |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Background |
| Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB; PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012 May 3;366(18):1696-704. doi: 10.1056/NEJMoa1202277. Epub 2012 Mar 26. |
| 22496081 | Background | Fraccaro C, Al-Lamee R, Tarantini G, Maisano F, Napodano M, Montorfano M, Frigo AC, Iliceto S, Gerosa G, Isabella G, Colombo A. Transcatheter aortic valve implantation in patients with severe left ventricular dysfunction: immediate and mid-term results, a multicenter study. Circ Cardiovasc Interv. 2012 Apr;5(2):253-60. doi: 10.1161/CIRCINTERVENTIONS.111.964213. Epub 2012 Apr 10. |
| D014694 |
| Ventricular Outflow Obstruction |