RecruitingPhase 2NCT06851949

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

Sponsor

Cardiac Success

Enrollment

20 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure With Reduced Ejection Fraction

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

Age≥18 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 Criteria27

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 index procedure
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