Status:
NOT_YET_RECRUITING
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients with Heart Failure
Lead Sponsor:
Cardiac Success
Conditions:
HFrEF - Heart Failure with Reduced Ejection Fraction
Eligibility:
All Genders
18-85 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Age≥ 18 and \< 85 years
- Left ventricular end diastolic diameter is greater than or equal to 55mm
- Ejection fraction ≥20% and ≤40%
- FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography (via a transthoracic or transesophageal echo)
- End-systolic Interpapillary muscle distance ≥ 20mm
- NYHA class II-IVa
- Cardiomyopathy of ischemic or non-ischemic origins
- Understands the nature of the study and procedure and able to provide written informed consent
Exclusion
- Any evidence of structural (chordal or leaflet) mitral lesions
- Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion in this study
- Prior mitral valve repair or replacement
- ICD/CRT/cardiac pacemaker leads implanted within 3 months prior to inclusion in this study
- Clinical signs of cardiogenic shock within 30 days prior to inclusion in this study
- Anatomy that, in the opinion of the interventionalist, prevents safe passage of the Vsling™ catheter(s).
- Severe aortic stenosis
- Severe, massive, or torrential tricuspid regurgitation requiring surgical or transcatheter repair
- Known fixed pulmonary hypertension with PA systolic pressure \>70 mmHg not responsive to vasodilator therapy
- ST segment elevation myocardial infarction within 30 days prior to inclusion in this study
- Congenital heart disease (except PFO, PDA or ASD)
- Heart Failure due to confirmed amyloid or other restrictive cardiomyopathies
- Chronic renal insufficiency defined by Creatinine ≥ 3.0 mg/dL or chronic renal replacement therapy
- Any therapeutic invasive cardiac procedure within 30 days prior to inclusion in the study
- Any cardiac surgery, within 3 months prior to inclusion in the study
- Cerebrovascular Accident (CVA) within 90 days prior to inclusion in this study
- Thrombocytopenia (Platelet count\< 100,000/mm3) or thrombocytosis (Platelet count \> 750,000/mm3)
- Body temperature \>38°C within 3 days prior to index procedure
- Bleeding disorders or hypercoagulable state
- Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant
- Contraindication to anticoagulants or antiplatelet agents
- Known allergy to stainless steel, nickel, titanium or contrast agents that cannot be adequately pre-medicated
- Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
- 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
- Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to \< 12 months
- 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
- Pregnancy
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06002386
Start Date
August 1 2025
End Date
December 1 2029
Last Update
January 3 2025
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