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Clinical Trials in Israel / NCT06851949
Recruiting Phase 2

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

NCT06851949 · tracked via the Priya Life Science Israel tracker
Sponsor
Cardiac Success
Phase
Phase 2
Started
2024-11-15
Last updated
2025-02-28

Condition(s) studied

Heart Failure With Reduced Ejection Fraction

Investigational drug(s) / intervention(s)

Vsling

Vsling: Implantable ventricular repair device

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Shamir Medical Center Be’er Ya‘aqov Israel Not Yet Recruiting
Rambam Medical Center Haifa Israel Recruiting
Hadassah Medical Center Jerusalem Israel Not Yet Recruiting
Rabin Medical Center Petah Tikva Israel Not Yet Recruiting
Tzafon Medical Center Poria – Neve Oved Israel Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06851949 on ClinicalTrials.gov ↗ ← All trials in Israel