NCT06851949 Vsling™ I: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
| NCT ID | NCT06851949 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cardiac Success |
| Condition | Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-11-15 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06851949 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06851949 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06851949 currently recruiting?
Yes, NCT06851949 is actively recruiting participants. Contact the research team at tami.a@cardiacsuccess.com for enrollment information.
Where is the NCT06851949 trial being conducted?
This trial is being conducted at Be’er Ya‘aqov, Israel, Haifa, Israel, Jerusalem, Israel, Petah Tikva, Israel and 1 additional location.
Who is sponsoring the NCT06851949 clinical trial?
NCT06851949 is sponsored by Cardiac Success. The trial plans to enroll 20 participants.
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