Status:
WITHDRAWN
Use of Cardiac-MRI to Predict Results for People With Severe Aortic Stenosis
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsors:
Medstar Health Research Institute
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
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 w...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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:
- Cardiac pacemaker or implantable defibrillator
- Cerebral aneurysm clip
- Neural stimulator (e.g. TENS-Unit)
- Any type of ear implant
- Ocular foreign body (e.g. metal shavings)
- Any implanted device (e.g. insulin pump, drug infusion device)
- Metal shrapnel or bullet.
- Atrial fibrillation
- 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:
- Known hypersensitivity to adenosine
- Known or suspected significant bronchoconstrictive or bronchospastic disease
- 2nd or 3rd degree atrioventricular (AV) block unless with permanent pacemaker
- Sinus bradycardia (heart rate \< 45 bpm) unless with permanent pacemaker
- Systemic arterial hypotension (\< 90 mmHg)
- 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).
Exclusion
Key Trial Info
Start Date :
June 27 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01905852
Start Date
June 27 2013
End Date
December 31 2016
Last Update
September 13 2019
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