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Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study (SITRAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830204
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at high-risk for mitral valve surgery or deemed inoperable due to the extent of calcification.

Condition or disease Intervention/treatment Phase
Mitral Annular Calcification Device: Mitral Valve Replacement with Sapien3 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Experimental: Mitral Valve Replacement with Sapien3
subjects with surgical MVR with Sapien3
Device: Mitral Valve Replacement with Sapien3
subjects with surgical MVR with Sapien3
Other Name: MVR




Primary Outcome Measures :
  1. Procedural success [ Time Frame: 30 days ]

    Procedural Success is defined as:

    1. Device success, and
    2. No device or procedure related serious adverse events (SAEs) (Life threatening bleed; major vascular or cardiac structural complications requiring unplanned reintervention or surgery; stage 2 or 3 acute kidney injury (AKI) (includes new dialysis); myocardial infarction (MI) or need for percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG); severe heart failure (HF) or hypotension requiring intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support; prolonged intubation ( > 48 hours)

  2. Technical success [ Time Frame: Procedure Stop Time ]

    Technical Success is defined as:

    1. Alive, with
    2. Successful access, delivery and retrieval of the device delivery system, and
    3. Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and
    4. No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure

  3. Device success [ Time Frame: 30 days ]

    Device Success is defined as:

    1. Alive and stroke free, with
    2. Original intended device in place, and
    3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/operating room (OR)), and
    4. Intended performance of the device:

      1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and
      2. Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = mitral valve area (MVA) < 1.5cm2 and mitral valve (MV) gradient > 5mmHg, Insufficiency = mitral regurgitation (MR) >1+), and
      3. Absence of para-device complications (e.g., paravalvular leak (PVL) > mild, need for a permanent pacemaker (PPM), erosion, Annular rupture or aortic valve (AV) Groove disruption, left ventricular outflow tract (LVOT) gradient increase > 10mmHg)


Secondary Outcome Measures :
  1. Device success [ Time Frame: 6 months ]

    Device Success is defined as:

    1. Alive and stroke free, with
    2. Original intended device in place, and
    3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/operating room (OR)), and
    4. Intended performance of the device:

      1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and
      2. Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = MVA < 1.5cm2 and MV gradient > 5mmHg, Insufficiency = MR >1+), and
      3. Absence of para-device complications (e.g., PVL > mild, need for a PPM, erosion, Annular rupture or AV Groove disruption, LVOT gradient increase > 10mmHg)

  2. Device Success [ Time Frame: 1 year ]

    Device Success is defined as:

    1. Alive and stroke free, with
    2. Original intended device in place, and
    3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/OR), and
    4. Intended performance of the device:

      1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and
      2. Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = MVA < 1.5cm2 and MV gradient > 5mmHg, Insufficiency = MR >1+), and
      3. Absence of para-device complications (e.g., PVL > mild, need for a PPM, erosion, Annular rupture or AV Groove disruption, LVOT gradient increase > 10mmHg)

  3. Subject success [ Time Frame: 1 year ]

    Subject Success is defined as:

    All of the following must be present:

    I. Device success (either optimal or acceptable), and II. Patient returned to the pre-procedural setting: and III. No rehospitalizations or reinterventions for the underlying condition (e.g., mitral regurgitation, heart failure); and IV. Improvement from baseline in symptoms (e.g., NYHA improvement by > or = 1 functional class); and V. Improvement from baseline in functional status (e.g., 6-min walk test improvement by > or = 50 m); and VI. Improvement from baseline in quality-of-life (e.g., Kansas City Cardiomyopathy Questionnaire improvement by > or = 10)




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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has severe native mitral annular calcification associated with mitral stenosis and/or regurgitation. Qualifying echo must be within 60 days of the date of the procedure.
  • Subject has a clinical indication for mitral valve replacement, as demonstrated by reported New York Heart Association (NYHA) Functional Class II or greater.
  • The subject is at least 22 years old.
  • The Heart Team agrees that the subject is high risk or inoperable for surgical mitral valve repair or replacement (MVR), based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. The following concomitant procedures, are allowed: MAZE, Tricuspid Valve Procedures (TVP), and Atrial Fibrillation (AF) ablation, coronary artery bypass grafting and septal myectomy.
  • The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  • The study subject agrees to comply with all required post-procedure follow-up visits

Exclusion Criteria:

  • Evidence of an acute myocardial infarction (MI) ≤ 30 days before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
  • Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease).
  • Leukopenia (white blood cell count < 2000 cell/mL), acute anemia (hemoglobin < 8 g/dL), or thrombocytopenia (platelet count < 50,000 cell/mL).
  • Hemodynamic or respiratory instability requiring vasoactive medications, mechanical ventilation at time of procedure.
  • Need for emergency surgery for any reason.
  • Severe left ventricular dysfunction with Left Ventricular Ejection Fraction (LVEF) < 30%.
  • Severe right ventricular dysfunction
  • Pregnancy, lactation, or planning to become pregnant
  • Echocardiographic evidence of left ventricular mass, thrombus, or concerns of active infective endocarditis.
  • Active upper gastrointestinal (GI) bleeding within 3 months prior to procedure without treatment or 30 days prior to procedure with definitive treatment.
  • A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be maintained on oral anticoagulant following the study procedure.
  • End stage renal disease requiring dialysis
  • Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 30 days of the procedure.
  • Estimated life expectancy < 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830204


Contacts
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Contact: Megan White, M.S 469-814-4181 Megan.White1@bswhealth.org
Contact: Kristen Chionh, M.S. 469-814-4736 Kristen.chionh@bswhealth.org

Locations
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United States, Indiana
St. Vincent Heart Center Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Jana Fisher, RN, BSN    317-583-7804    Jana.Fisher@ascension.org   
Principal Investigator: David Heimansohn, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Micahel Fusilero    212-241-8905    michael.fusilero@mountsinai.org   
Principal Investigator: Ahmed El-Eshmawi, MD         
United States, Pennsylvania
Lankenau Institute for Medical Research Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Sherry McDermott    484-476-8514    McDermottS@mlhs.org   
Principal Investigator: Scott Goldman, MD         
United States, Texas
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Necole Kell, RN    469-814-4871 ext 4871    Necole.Kell@BSWHealth.org   
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Rachel Simon, RN, BSN, CCRC    434-243-7654 ext 7654    rmg5r@hscmail.mcc.virginia.edu   
Principal Investigator: Gorav Ailawadi, MD         
Sponsors and Collaborators
Baylor Research Institute
Edwards Lifesciences
Investigators
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Principal Investigator: Robert Smith, MD Baylor Research Institute
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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02830204    
Other Study ID Numbers: 016-100
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is currently no plan to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Baylor Research Institute:
mitral valve regurgitation
mitral valve stenosis
Additional relevant MeSH terms:
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Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases