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

Launched by CARDIAC SUCCESS · Feb 24, 2025

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ClinConnect Summary

The Vsling™ I clinical trial is studying a new device called the Vsling™ that is designed to help repair the heart in patients who have heart failure, specifically those with a condition where the heart's pumping ability is reduced. This trial is looking for participants who are at least 18 years old and have certain heart measurements, such as a left ventricular size of 55mm or more and an ejection fraction (a measure of how well the heart pumps blood) between 20% and 40%. Participants should also have mild heart valve issues and be in a certain class of heart failure symptoms.

If you or a family member qualify and choose to participate, you'll be part of a study that is assessing the safety and effectiveness of the Vsling™ device. The study is currently recruiting participants and will involve checking your heart health through tests like echocardiograms. It's important to note that certain medical conditions, such as severe heart valve problems or recent heart surgeries, may prevent someone from joining the trial. Overall, this study aims to explore a new approach to improving heart function and the quality of life for people with heart failure.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age≥18 years
• • 2. Left ventricular end diastolic diameter is greater than or equal to 55mm
• • 3. Ejection fraction ≥20% and ≤40%
• • 4. FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography (via a transthoracic or transesophageal echo)
• • 5. End-systolic Interpapillary muscle distance ≥ 20mm
• • 6. NYHA class II-IVa
• • 7. Cardiomyopathy of ischemic or non-ischemic origins
• • 8. Understands the nature of the study and procedure and able to provide written informed consent
• Exclusion Criteria:
• • 1. Any evidence of structural (chordal or leaflet) mitral lesions
• • 2. Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion in this study
• • 3. Prior mitral valve repair or replacement
• • 4. ICD/CRT/cardiac pacemaker leads implanted within 3 months prior to inclusion in this study
• • 5. Clinical signs of cardiogenic shock within 30 days prior to inclusion in this study
• • 6. Anatomy that, in the opinion of the interventionalist, prevents safe passage of the Vsling™ catheter(s).
• • 7. Severe aortic stenosis
• • 8. Severe, massive, or torrential tricuspid regurgitation requiring surgical or transcatheter repair
• • 9. Known fixed pulmonary hypertension with PA systolic pressure \>70 mmHg not responsive to vasodilator therapy
• • 10. ST segment elevation myocardial infarction within 30 days prior to inclusion in this study
• • 11. Congenital heart disease (except PFO, PDA or ASD)
• • 12. Heart Failure due to confirmed amyloid or other restrictive cardiomyopathies
• • 13. Chronic renal insufficiency defined by Creatinine ≥ 3.0 mg/dL or chronic renal replacement therapy
• • 14. Any therapeutic invasive cardiac procedure within 30 days prior to index procedure
• • 15. Any cardiac surgery, within 3 months prior to inclusion in the study
• • 16. Cerebrovascular Accident (CVA) within 90 days prior to inclusion in this study
• • 17. Thrombocytopenia (Platelet count\< 100,000/mm3) or thrombocytosis (Platelet count \> 750,000/mm3)
• • 18. Body temperature \>38°C within 3 days prior to index procedure
• • 19. Bleeding disorders or hypercoagulable state
• • 20. Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant
• • 21. Contraindication to anticoagulants or antiplatelet agents
• • 22. Known allergy to stainless steel, nickel, titanium or contrast agents that cannot be adequately pre-medicated
• • 23. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
• • 24. 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
• • 25. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to \< 12 months
• • 26. 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
• • 27. Pregnancy