Evaluation of the Vsling™ Device for Heart Failure Treatment
Vsling™ I: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
This study is testing a new device called Vsling™ to see if it can help people with heart failure feel better by repairing their heart's function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardiac Success Industry-sponsored |
| Locations | 5 sites (Be’er Ya‘aqov and 4 other locations) |
| Trial ID | NCT06851949 on ClinicalTrials.gov |
What this trial studies
This clinical evaluation focuses on the Vsling™ device, which is designed for ventricular repair in patients suffering from heart failure with reduced ejection fraction. The study is prospective, multi-center, and open-label, assessing the feasibility, safety, and performance of the device in patients with significant left ventricular dilation. Participants will be monitored for their heart function and overall health outcomes following the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with heart failure characterized by reduced ejection fraction and specific anatomical criteria.
Not a fit: Patients with structural mitral lesions or recent serious cardiac events may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this device could significantly improve heart function and quality of life for patients with heart failure.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in the field of heart failure interventions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Be’er Ya‘aqov and 4 other locations
- 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)
Study contacts
- Study coordinator: Tami Abudi, +972
- Email: tami.a@cardiacsuccess.com
- Phone: +972 (52) 5989833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.