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Recruiting NCT06851949

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

Phase II Interventional Heart Failure With Reduced Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vsling.
Who it may be relevant to
Registry conditions: Heart Failure With Reduced Ejection Fraction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device Vsling
    Implantable ventricular repair device

Primary outcome measures

  • Device related Serious Adverse Events (SAE) [Time frame: 30 Days]

Eligibility criteria

Inclusion criteria

  • Age≥18 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 criteria

  • 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 index procedure
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 5 centers
  • Shamir Medical Center — Be’er Ya‘aqov
  • Rambam Medical Center — Haifa
  • Hadassah Medical Center — Jerusalem
  • Rabin Medical Center — Petah Tikva
  • Tzafon Medical Center — Poria – Neve Oved

Identifiers

NCT: NCT06851949 · CL-9003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗