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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Implantable ventricular repair device
Shamir Medical Center
Be’er Ya‘aqov, Israel
NOT_YET_RECRUITINGRambam Medical Center
Haifa, Israel
RECRUITINGHadassah Medical Center
Jerusalem, Israel
NOT_YET_RECRUITINGDevice related Serious Adverse Events (SAE)
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
Time frame: 30 Days
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Rabin Medical Center
Petah Tikva, Israel
NOT_YET_RECRUITINGTzafon Medical Center
Poria – Neve Oved, Israel
RECRUITING