xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06034028</url>
    </required_header>
    <id_info>
      <org_study_id>JCM-001</org_study_id>
      <nct_id>NCT06034028</nct_id>
    </id_info>
    <brief_title>J-Valve TF Early Feasibility Study</brief_title>
    <acronym>JVTF EFS</acronym>
    <official_title>J-Valve TF Early Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>JC Medical, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>JC Medical, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main objective of this study is to assess the preliminary safety and effectiveness of the&#xD;
        J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are&#xD;
        judged by a multi-disciplinary heart team to be eligible for the device and to be at high&#xD;
        risk for open surgical aortic valve replacement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The EFS is a prospective, single arm, multi-center, interventional study that will enroll up&#xD;
        to 15 subjects in up to 10 centers in the United States and/or Canada and report the primary&#xD;
        endpoint of all-cause death or disabling stroke at 30 days.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">January 30, 2029</completion_date>
    <primary_completion_date type="Anticipated">January 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients that do not experience death or disabling stroke</measure>
      <time_frame>30 days after the valve procedure</time_frame>
      <description>Freedom from death or disabling stroke Disabling stroke is evaluated using a standardized scale</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of patients and procedures achieving technical success</measure>
      <time_frame>At point patient exits the procedure room</time_frame>
      <description>Procedures achieving the following:&#xD;
  Patient is alive;&#xD;
  There was successful access, delivery of the valve, and retrieval of the delivery device;&#xD;
  There was correct positioning of a single prosthetic heart valve into the proper anatomical location;&#xD;
  There was no need for surgery or intervention due to the device, except permanent pacemaker placement, or for a major complication that it vascular, access-related, or cardiac in nature</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients and procedures achieving device success</measure>
      <time_frame>30 days after the valve procedure</time_frame>
      <description>There was successful access, delivery of the valve, and retrieval of the delivery device;&#xD;
  There was correct positioning of a single prosthetic heart valve into the proper anatomical location;&#xD;
  There was no need for surgery or intervention due to the device, except permanent pacemaker placement, or for a major complication that it vascular, access-related, or cardiac in nature;&#xD;
  Patient is alive;&#xD;
  There was not surgery or intervention due to the device, except permanent pacemaker placement, or for a major complication that it vascular, access-related, or cardiac in nature;&#xD;
  The valve was performing as intended, measured by echocardiography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with a safety-related event outcome</measure>
      <time_frame>30 days after the valve procedure</time_frame>
      <description>Freedom from:&#xD;
  All-cause death;&#xD;
  All stroke;&#xD;
  Valve Academic Research Consortium (VARC)-3 type 2-4 bleeding;&#xD;
  Major vascular, access-related, or cardiac structural complication;&#xD;
  Acute kidney injury stage 3 or 4;&#xD;
  Moderate or severe aortic regurgitation;&#xD;
  New permanent pacemaker due to procedure related conduction abnormalities;&#xD;
  Surgery or intervention related to the device.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients experiencing success</measure>
      <time_frame>1 year after the valve procedure</time_frame>
      <description>No re-hospitalization or re-interventions for the underlying condition and improvement, from baseline, in symptoms, which are measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score.&#xD;
  Success in an increase from baseline of 10 or more points on the KCCQ-OS score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients meeting clinical efficacy outcome at 2 years</measure>
      <time_frame>2 years after the valve procedure</time_frame>
      <description>Freedom-from all-cause death;&#xD;
  Freedom from all stroke;&#xD;
  Freedom from hospitalization for procedure- or valve-related causes;&#xD;
  Freedom from KCCQ-OS score &lt; 45 or decline from baseline of &gt;10 points;&#xD;
  Good Outcome: Alive with change in KCCQ-OS score &gt;=10 points;&#xD;
  Excellent outcome: Alive with change in KCCQ-OS score &gt;=20 points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients meeting clinical efficacy outcome at 3 years</measure>
      <time_frame>3 years after the valve procedure</time_frame>
      <description>Freedom-from all-cause death;&#xD;
  Freedom from all stroke;&#xD;
  Freedom from hospitalization for procedure- or valve-related causes;&#xD;
  Freedom from KCCQ-OS score &lt; 45 or decline from baseline of &gt;10 points;&#xD;
  Good Outcome: Alive with change in KCCQ-OS score &gt;=10 points;&#xD;
  Excellent outcome: Alive with change in KCCQ-OS score &gt;=20 points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients meeting clinical efficacy outcome at 4 years</measure>
      <time_frame>4 years after the valve procedure</time_frame>
      <description>Freedom-from all-cause death;&#xD;
  Freedom from all stroke;&#xD;
  Freedom from hospitalization for procedure- or valve-related causes;&#xD;
  Freedom from KCCQ-OS score &lt; 45 or decline from baseline of &gt;10 points;&#xD;
  Good Outcome: Alive with change in KCCQ-OS score &gt;=10 points;&#xD;
  Excellent outcome: Alive with change in KCCQ-OS score &gt;=20 points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients meeting clinical efficacy outcome at 5 years</measure>
      <time_frame>5 years after the valve procedure</time_frame>
      <description>Freedom-from all-cause death;&#xD;
  Freedom from all stroke;&#xD;
  Freedom from hospitalization for procedure- or valve-related causes;&#xD;
  Freedom from KCCQ-OS score &lt; 45 or decline from baseline of &gt;10 points;&#xD;
  Good Outcome: Alive with change in KCCQ-OS score &gt;=10 points;&#xD;
  Excellent outcome: Alive with change in KCCQ-OS score &gt;=20 points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients achieving long-term clinical efficacy for valve function</measure>
      <time_frame>5 years after the valve procedure</time_frame>
      <description>Freedom from:&#xD;
  Bioprosthetic valve failure (defined as Valve-related mortality or aortic valve re-operation/re-intervention or Stage 3 hemodynamic valve deterioration);&#xD;
  Stroke or peripheral embolism (presumably valve- related, after ruling out other non-valve etiologies);&#xD;
  VARC-3 Type 2-4 bleeding secondary to or exacerbated by antiplatelet&#xD;
  or anticoagulant agents, used specifically for valve- related concerns.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Aortic Valve Disease</condition>
    <condition>Aortic Valve Insufficiency</condition>
    <condition>Aortic Regurgitation</condition>
    <arm_group>
      <arm_group_label>J-Valve TF System</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>J-Valve TF System</intervention_name>
      <description>The J-Valve TF System is a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis, J-Valve TF Delivery Device, and Loading Accessories.</description>
      <arm_group_label>J-Valve TF System</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient has symptomatic (NYHA FC ≥ IIs) severe (≥3+) native AR (per 2020 ACC/AHA&#xD;
               Guideline for Management of Patients with Valvular Heart Disease) diagnosed by&#xD;
               echocardiography. Patients will be assessed according to the current American Society&#xD;
               of Echocardiography Guidelines for Non-invasive Evaluation of Native Valve&#xD;
               Regurgitation. Transesophageal echocardiography (TEE) or cardiac MRI (CMR) will be&#xD;
               used in case of indeterminant AR;&#xD;
  &#xD;
            -  Patient is judged by a multi-disciplinary heart team to be at high risk for surgery,&#xD;
               based on the ACC/AHA guidelines for management of patients with valvular heart&#xD;
               disease: STS-PROM score ≥8%, or if &lt;8%, significant co-morbidities that are not&#xD;
               captured by the STS-PROM score (e.g., ≥2 frailty indices, 1 to 2 major organ system&#xD;
               compromise, the presence of certain procedure-specific factors that affect surgical&#xD;
               mortality), based on the consensus of a multi-disciplinary heart team;&#xD;
  &#xD;
            -  Patient has suitable anatomy for J-Valve implantation;&#xD;
  &#xD;
            -  Patient or the patient's legal representative has provided written informed consent;&#xD;
  &#xD;
            -  Patient or patient's legal representative agrees to comply with all required&#xD;
               post-procedure follow-up visits.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients that are at prohibitive surgical risk (predicted risk for mortality or major&#xD;
               morbidity at 30 days &gt;50% with SAVR);&#xD;
  &#xD;
            -  Mixed aortic valve disease, defined as coexistence of &gt; moderate aortic valve stenosis&#xD;
               with severe AR;&#xD;
  &#xD;
            -  Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin,&#xD;
               ticlopidine, clopidogrel, Nitinol (Nickel, Titanium, Aluminum) or sensitivity to&#xD;
               contrast media, which cannot be adequately premedicated;&#xD;
  &#xD;
            -  Blood dyscrasias as defined: leukopenia (WBC &lt;1000 mm3), thrombocytopenia (platelet&#xD;
               count &lt;50,000 cells/mm3), history of bleeding diathesis or coagulopathy;&#xD;
  &#xD;
            -  Active infection, including infective endocarditis;&#xD;
  &#xD;
            -  Liver failure (Child-C);&#xD;
  &#xD;
            -  Reduced left ventricular function with left ventricular ejection fraction (LVEF) &lt;25%&#xD;
               as measured by resting echocardiogram;&#xD;
  &#xD;
            -  Uncontrolled atrial fibrillation (e.g., resting heart rate &gt;120 bpm);&#xD;
  &#xD;
            -  Pregnancy or intent to become pregnant prior to completion of all protocol follow-up&#xD;
               requirements;&#xD;
  &#xD;
            -  Renal insufficiency (eGFR &lt;25) and/or end stage renal disease requiring chronic&#xD;
               dialysis;&#xD;
  &#xD;
            -  Pulmonary Hypertension (systolic pressure ≥2/3 of systemic);&#xD;
  &#xD;
            -  Severe Chronic Obstructive Pulmonary Disease (COPD) = requiring steroids or requiring&#xD;
               continuous home O2&#xD;
  &#xD;
            -  Severe mitral or severe tricuspid regurgitation or stenosis;&#xD;
  &#xD;
            -  Symptomatic carotid or vertebral artery disease or successful treatment of carotid&#xD;
               stenosis within six weeks of treatment;&#xD;
  &#xD;
            -  Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or&#xD;
               mechanical hemodynamic support;&#xD;
  &#xD;
            -  Recent (within 6 months of treatment) cerebrovascular accident (CVA) or transient&#xD;
               ischemic attack (TIA);&#xD;
  &#xD;
            -  Active gastrointestinal (GI) bleeding that would preclude anticoagulation;&#xD;
  &#xD;
            -  Untreated multivessel coronary artery disease with a Syntax score &gt;22 and/or&#xD;
               unprotected left main coronary artery;&#xD;
  &#xD;
            -  Evidence of acute myocardial infarction within 1 month of intended procedure;&#xD;
  &#xD;
            -  Estimated life expectancy of less than 24 months due to associated (excluding cardiac)&#xD;
               co-morbid conditions;&#xD;
  &#xD;
            -  Left Ventricular Assist Device (LVAD) dependent;&#xD;
  &#xD;
            -  Participating in another study that may influence the outcome of this study;&#xD;
  &#xD;
            -  Need for emergency surgery for any reason;&#xD;
  &#xD;
            -  Previous aortic bioprosthesis or mechanical implant.&#xD;
  &#xD;
          Anatomic Exclusion Criteria:&#xD;
  &#xD;
            -  Ascending Aortic diameter &gt;5 cm;&#xD;
  &#xD;
            -  Aortic Annulus Perimeter &lt;57 mm or &gt;104 mm;&#xD;
  &#xD;
            -  Access vessel minimum diameter &lt;5.5 mm;&#xD;
  &#xD;
            -  LVEDD &gt;75 mm;&#xD;
  &#xD;
            -  Bicuspid aortic valve disease;&#xD;
  &#xD;
            -  Congenital univentricle or other condition that, in the opinion of the investigator&#xD;
               and/or consulting physician, may constitute an unwarranted surgical risk.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dean J Kereiakes, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Christ Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Michael J Reardon, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Methodist Hospital Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Affairs</last_name>
      <phone>650-477-2781</phone>
      <email>info@jcmedicalinc.com</email>
    </overall_contact>
    <link>
      <url>http://j-valve.com</url>
      <description>JC Medical, Inc. company website.</description>
    </link>
    <reference>
      <citation>Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021 Feb 2;77(4):e25-e197. doi: 10.1016/j.jacc.2020.11.018. Epub 2020 Dec 17. No abstract available. Erratum In: J Am Coll Cardiol. 2021 Feb 2;77(4):509. J Am Coll Cardiol. 2021 Mar 9;77(9):1275. J Am Coll Cardiol. 2023 Aug 29;82(9):969.</citation>
      <PMID>33342586</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>J-Valve TF System</keyword>
    <keyword>Transcatheter Aortic Valve Replacement</keyword>
    <keyword>Transcatheter Aortic Valve Implantation</keyword>
    <keyword>Transcatheter Heart Valve</keyword>
    <keyword>Transfemoral</keyword>
    <keyword>TAVR</keyword>
    <keyword>TAVI</keyword>
    <keyword>THV</keyword>
    <keyword>VHD</keyword>
    <keyword>Valvular Heart Disease</keyword>
    <keyword>Valve Disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aortic Valve Disease</mesh_term>
      <mesh_term>Aortic Valve Insufficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06034028
  org study id: JCM-001
  nct id: NCT06034028
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  The main objective of this study is to assess the preliminary safety and effectiveness of the
        J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are
        judged by a multi-disciplinary heart team to be eligible for the device and to be at high
        risk for open surgical aortic valve replacement.
  The EFS is a prospective, single arm, multi-center, interventional study that will enroll up
        to 15 subjects in up to 10 centers in the United States and/or Canada and report the primary
        endpoint of all-cause death or disabling stroke at 30 days.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of patients that do not experience death or disabling stroke
  time frame: 30 days after the valve procedure
  description: Freedom from death or disabling stroke Disabling stroke is evaluated using a standardized scale
  measure: Number of patients and procedures achieving technical success
  time frame: At point patient exits the procedure room
  description: Procedures achieving the following:
  Patient is alive;
  There was successful access, delivery of the valve, and retrieval of the delivery device;
  There was correct positioning of a single prosthetic heart valve into the proper anatomical location;
  There was no need for surgery or intervention due to the device, except permanent pacemaker placement, or for a major complication that it vascular, access-related, or cardiac in nature
  measure: Number of patients and procedures achieving device success
  time frame: 30 days after the valve procedure
  description: There was successful access, delivery of the valve, and retrieval of the delivery device;
  There was correct positioning of a single prosthetic heart valve into the proper anatomical location;
  There was no need for surgery or intervention due to the device, except permanent pacemaker placement, or for a major complication that it vascular, access-related, or cardiac in nature;
  Patient is alive;
  There was not surgery or intervention due to the device, except permanent pacemaker placement, or for a major complication that it vascular, access-related, or cardiac in nature;
  The valve was performing as intended, measured by echocardiography
  measure: Number of patients with a safety-related event outcome
  time frame: 30 days after the valve procedure
  description: Freedom from:
  All-cause death;
  All stroke;
  Valve Academic Research Consortium (VARC)-3 type 2-4 bleeding;
  Major vascular, access-related, or cardiac structural complication;
  Acute kidney injury stage 3 or 4;
  Moderate or severe aortic regurgitation;
  New permanent pacemaker due to procedure related conduction abnormalities;
  Surgery or intervention related to the device.
  measure: Number of patients experiencing success
  time frame: 1 year after the valve procedure
  description: No re-hospitalization or re-interventions for the underlying condition and improvement, from baseline, in symptoms, which are measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score.
  Success in an increase from baseline of 10 or more points on the KCCQ-OS score.
  measure: Number of patients meeting clinical efficacy outcome at 2 years
  time frame: 2 years after the valve procedure
  description: Freedom-from all-cause death;
  Freedom from all stroke;
  Freedom from hospitalization for procedure- or valve-related causes;
  Freedom from KCCQ-OS score < 45 or decline from baseline of >10 points;
  Good Outcome: Alive with change in KCCQ-OS score >=10 points;
  Excellent outcome: Alive with change in KCCQ-OS score >=20 points.
  measure: Number of patients meeting clinical efficacy outcome at 3 years
  time frame: 3 years after the valve procedure
  description: Freedom-from all-cause death;
  Freedom from all stroke;
  Freedom from hospitalization for procedure- or valve-related causes;
  Freedom from KCCQ-OS score < 45 or decline from baseline of >10 points;
  Good Outcome: Alive with change in KCCQ-OS score >=10 points;
  Excellent outcome: Alive with change in KCCQ-OS score >=20 points.
  measure: Number of patients meeting clinical efficacy outcome at 4 years
  time frame: 4 years after the valve procedure
  description: Freedom-from all-cause death;
  Freedom from all stroke;
  Freedom from hospitalization for procedure- or valve-related causes;
  Freedom from KCCQ-OS score < 45 or decline from baseline of >10 points;
  Good Outcome: Alive with change in KCCQ-OS score >=10 points;
  Excellent outcome: Alive with change in KCCQ-OS score >=20 points.
  measure: Number of patients meeting clinical efficacy outcome at 5 years
  time frame: 5 years after the valve procedure
  description: Freedom-from all-cause death;
  Freedom from all stroke;
  Freedom from hospitalization for procedure- or valve-related causes;
  Freedom from KCCQ-OS score < 45 or decline from baseline of >10 points;
  Good Outcome: Alive with change in KCCQ-OS score >=10 points;
  Excellent outcome: Alive with change in KCCQ-OS score >=20 points.
  measure: Number of patients achieving long-term clinical efficacy for valve function
  time frame: 5 years after the valve procedure
  description: Freedom from:
  Bioprosthetic valve failure (defined as Valve-related mortality or aortic valve re-operation/re-intervention or Stage 3 hemodynamic valve deterioration);
  Stroke or peripheral embolism (presumably valve- related, after ruling out other non-valve etiologies);
  VARC-3 Type 2-4 bleeding secondary to or exacerbated by antiplatelet
  or anticoagulant agents, used specifically for valve- related concerns.
  arm group label: J-Valve TF System
  arm group type: Experimental
  intervention type: Device
  intervention name: J-Valve TF System
  description: The J-Valve TF System is a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis, J-Valve TF Delivery Device, and Loading Accessories.
  arm group label: J-Valve TF System
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Dean J Kereiakes, MD
  role: Principal Investigator
  affiliation: The Christ Hospital
  last name: Michael J Reardon, MD
  role: Principal Investigator
  affiliation: The Methodist Hospital Research Institute
  last name: Clinical Affairs
  phone: 650-477-2781
  email: info@jcmedicalinc.com
  url: http://j-valve.com
  description: JC Medical, Inc. company website.
  citation: Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021 Feb 2;77(4):e25-e197. doi: 10.1016/j.jacc.2020.11.018. Epub 2020 Dec 17. No abstract available. Erratum In: J Am Coll Cardiol. 2021 Feb 2;77(4):509. J Am Coll Cardiol. 2021 Mar 9;77(9):1275. J Am Coll Cardiol. 2023 Aug 29;82(9):969.
  PMID: 33342586
  responsible party type: Sponsor
  mesh term: Aortic Valve Disease
  mesh term: Aortic Valve Insufficiency
  sharing ipd: No