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

Study Overview
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Brief Summary
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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.

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

Conditions
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HFrEF - Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
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* Device: Vsling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vsling device<br>Vsling device implantation | Device: Vsling<br>* Implantable ventricular repair device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days |