RecruitingPhase 2NCT06851949

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


Sponsor

Cardiac Success

Enrollment

20 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new implantable device called the Vsling, which is placed around the heart through a minimally invasive procedure to physically support a weakened, enlarged heart and help it pump more efficiently in patients with heart failure. **You may be eligible if...** - You are 18 years of age or older - Your left ventricle (main pumping chamber) is significantly enlarged (end diastolic diameter ≥ 55 mm) - Your heart's pumping function (ejection fraction) is between 20% and 40% - Your heart valve leakage (mitral regurgitation) is mild or less - You have moderate-to-severe heart failure symptoms (NYHA Class II–IVa) - Your heart failure is caused by ischemic or non-ischemic dilated cardiomyopathy **You may NOT be eligible if...** - Your ejection fraction is below 20% or above 40% - Your mitral valve leakage is moderate or greater - You have had a recent heart attack or heart surgery - You have a mechanical heart valve or a device that would interfere with the Vsling - You are listed for or have had a heart transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVsling

Implantable ventricular repair device


Locations(5)

Shamir Medical Center

Be’er Ya‘aqov, Israel

Rambam Medical Center

Haifa, Israel

Hadassah Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

Tzafon Medical Center

Poria – Neve Oved, Israel

View Full Details on ClinicalTrials.gov

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NCT06851949


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