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Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure (Vsling III)

Primary Purpose

HFrEF - Heart Failure With Reduced Ejection Fraction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vsling
Sponsored by
Cardiac Success
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for HFrEF - Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age≥ 18 and < 85 years Left ventricular end diastolic diameter is greater than or equal to 55mm Ejection fraction ≥20% and ≤40% FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography (via a transthoracic or transesophageal echo) End-systolic Interpapillary muscle distance ≥ 20mm NYHA class II-IVa Cardiomyopathy of ischemic or non-ischemic origins Understands the nature of the study and procedure and able to provide written informed consent Exclusion Criteria: Any evidence of structural (chordal or leaflet) mitral lesions Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion in this study Prior mitral valve repair or replacement ICD/CRT/cardiac pacemaker leads implanted within 3 months prior to inclusion in this study Clinical signs of cardiogenic shock within 30 days prior to inclusion in this study Anatomy that, in the opinion of the interventionalist, prevents safe passage of the Vsling™ catheter(s). Severe aortic stenosis Severe, massive, or torrential tricuspid regurgitation requiring surgical or transcatheter repair Known fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy ST segment elevation myocardial infarction within 30 days prior to inclusion in this study Congenital heart disease (except PFO, PDA or ASD) Heart Failure due to confirmed amyloid or other restrictive cardiomyopathies Chronic renal insufficiency defined by Creatinine ≥ 3.0 mg/dL or chronic renal replacement therapy Any therapeutic invasive cardiac procedure within 30 days prior to inclusion in the study Any cardiac surgery, within 3 months prior to inclusion in the study Cerebrovascular Accident (CVA) within 90 days prior to inclusion in this study Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3) Body temperature >38°C within 3 days prior to index procedure Bleeding disorders or hypercoagulable state Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant Contraindication to anticoagulants or antiplatelet agents Known allergy to stainless steel, nickel, titanium or contrast agents that cannot be adequately pre-medicated Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Vsling device

    Arm Description

    Vsling device implantation

    Outcomes

    Primary Outcome Measures

    Device related Serious Adverse Events (SAE)
    Device related Serious Adverse Events (SAE) within 30 days of the procedure: any SAE that has been determined by the safety monitor to be related to the Vsling™ implantation procedure or the Vsling™ device

    Secondary Outcome Measures

    Full Information

    First Posted
    August 13, 2023
    Last Updated
    August 13, 2023
    Sponsor
    Cardiac Success
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06002386
    Brief Title
    Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
    Acronym
    Vsling III
    Official Title
    Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    October 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cardiac Success

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Prospective, multi-center, open-label clinical study of the feasibility and initial safety and performance of the Vsling™ in patients with heart failure (HF) with evidence of reduced left ventricular ejection fraction, associated with ventricular dilation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HFrEF - Heart Failure With Reduced Ejection Fraction

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vsling device
    Arm Type
    Experimental
    Arm Description
    Vsling device implantation
    Intervention Type
    Device
    Intervention Name(s)
    Vsling
    Intervention Description
    Implantable ventricular repair device
    Primary Outcome Measure Information:
    Title
    Device related Serious Adverse Events (SAE)
    Description
    Device related Serious Adverse Events (SAE) within 30 days of the procedure: any SAE that has been determined by the safety monitor to be related to the Vsling™ implantation procedure or the Vsling™ device
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age≥ 18 and < 85 years Left ventricular end diastolic diameter is greater than or equal to 55mm Ejection fraction ≥20% and ≤40% FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography (via a transthoracic or transesophageal echo) End-systolic Interpapillary muscle distance ≥ 20mm NYHA class II-IVa Cardiomyopathy of ischemic or non-ischemic origins Understands the nature of the study and procedure and able to provide written informed consent Exclusion Criteria: Any evidence of structural (chordal or leaflet) mitral lesions Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion in this study Prior mitral valve repair or replacement ICD/CRT/cardiac pacemaker leads implanted within 3 months prior to inclusion in this study Clinical signs of cardiogenic shock within 30 days prior to inclusion in this study Anatomy that, in the opinion of the interventionalist, prevents safe passage of the Vsling™ catheter(s). Severe aortic stenosis Severe, massive, or torrential tricuspid regurgitation requiring surgical or transcatheter repair Known fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy ST segment elevation myocardial infarction within 30 days prior to inclusion in this study Congenital heart disease (except PFO, PDA or ASD) Heart Failure due to confirmed amyloid or other restrictive cardiomyopathies Chronic renal insufficiency defined by Creatinine ≥ 3.0 mg/dL or chronic renal replacement therapy Any therapeutic invasive cardiac procedure within 30 days prior to inclusion in the study Any cardiac surgery, within 3 months prior to inclusion in the study Cerebrovascular Accident (CVA) within 90 days prior to inclusion in this study Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3) Body temperature >38°C within 3 days prior to index procedure Bleeding disorders or hypercoagulable state Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant Contraindication to anticoagulants or antiplatelet agents Known allergy to stainless steel, nickel, titanium or contrast agents that cannot be adequately pre-medicated Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Iris Yadin-Herling
    Phone
    972546633352
    Email
    iris.yh@cardiacsuccess.com

    12. IPD Sharing Statement

    Learn more about this trial

    Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure

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