Use of Cardiac-MRI to Predict Results for People With Severe Aortic Stenosis

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Coupling Modification Evaluated by PRAM During TAVI Procedure CoreValve Advance International Post Market Study HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON SWISS TAVI Registry CoreValve™ Evolut R™ FORWARD Study Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial Follow-up After TAVR Without Systematic Intensive Care Unit Admission ACURATE NEO/TF Transcatheter Heart Valves and Non-inferiority Versus Medtronic CoreValve Systems CoreValve™ Evolut R™ 34 mm System Registry (CoreValve34) Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR) ACURATE TA™ Valve Implantation Registry: SAVI 2 Colibri Transcatheter Aortic Heart Valve System Study HLT Meridian Valve CE Mark Trial Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small 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Aortic Stenosis Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis Phono- and Electrocardiogram Assisted Detection of Valvular Disease The Medtronic TAVR 2.0 US Clinical Study PREVAIL-J – Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan) Regression of Myocardial Fibrosis After Aortic Valve Replacement Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis THE ALIGN-AS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis Severe Aortic Valve Stenosis and 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Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed 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Brief Title

Use of Cardiac-MRI to Predict Results for People With Severe Aortic Stenosis

Official Title

Utilization of Cardiac Magnetic Resonance Imaging to Predict Clinical Outcomes of Patients With Severe Aortic Stenosis

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
      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:

        -  Participants will visit a clinic for 1 day for magnetic resonance imaging (MRI) of their
           heart. This uses magnets, radio waves, and computers to produce detailed pictures of the
           heart.

        -  After this visit, participants will have their aortic valve procedure at the the
           Washington Hospital Center. A hospital team will contact participants for 1 year by
           phone or email. This follow-up will consist of 15 minutes of questions about the
           participant s health status.

        -  Some participants will join a sub-study.

        -  They will be given an additional medication to evaluate the blood supply of the heart.

        -  They will visit a clinic for 1 day for an MRI of their heart, as part of the main study,
           prior to the aortic valve replacement.

        -  After they have their valve replaced at the hospital, they will return to the clinic for
           another MRI.

        -  They will have the same follow-up as in the main study.

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 the heart to identify which patients would benefit from replacement of
      the diseased valve.

Study Type

Observational

Primary Outcome

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.

Condition

Aortic Valve Stenosis

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

0

Start Date

June 27, 2013

Completion Date

December 31, 2016

Primary Completion Date

December 31, 2016

Eligibility Criteria

        -  INCLUSION CRITERIA:

        Subjects must meet all the following inclusion criteria prior to enrollment into the trial:

          1. 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.

          2. Symptomatic patients with aortic stenosis referred for medically indicated AVR

          3. LV EF less than or equal to 0.50

          4. Signed informed consent to participate in the study.

             Specific criteria for MR perfusion sub-study:

          5. Absence of any significant coronary lesions or presence of coronary disease for
             conservative (medical) therapy.

        EXCLUSION CRITERIA:

          1. Inability to sign written informed consent.

          2. 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

          3. Subjects with a known hypersensitivity, allergy or contraindication to iodine or
             gadolinium

          4. Impaired renal excretory function, calculated as Glomerular Filtration Rate (GFR)
             <30mL/min/1.73m(2).

          5. 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)

          6. Presence of any coexisting severe valvular disorder.

          7. Pregnancy or breast feeding (women of childbearing potential will have a serum or
             urine pregnancy test).

          8. Need for emergency surgery for any reason.

          9. 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).

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Andrew E Arai, M.D., ,

Administrative Informations

NCT ID

NCT01905852

Organization ID

130168

Secondary IDs

13-H-0168

Responsible Party

Sponsor

Study Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators

 Medstar Washington Hospital Center

Study Sponsor

Andrew E Arai, M.D., Principal Investigator, National Heart, Lung, and Blood Institute (NHLBI)

Verification Date

April 8, 2014