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

Recruiting Phase 2 Interventional Study
Heart Failure With Reduced Ejection Fraction
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Cardiac Success · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age≥18 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.…
Contacts

Tami Abudi, +972

+972 (52) 5989833

tami.a@cardiacsuccess.com

CONTACT