HFrEF - Heart Failure with Reduced Ejection Fraction
Conditions
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.
Interventions
DEVICEVsling
Implantable ventricular repair device
Sponsors
Cardiac Success
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age≥ 18 and \< 85 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 inclusion in the study 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device related Serious Adverse Events (SAE) | 30 days | Device related Serious Adverse Events (SAE) within 30 days of the procedure: any SAE that has been determined by the safety monitor to be related to the Vsling™ implantation procedure or the Vsling™ device |
Contacts
Primary ContactIris Yadin-Herling
Outcome results
None listed