Actively Recruiting
Vsling™ I: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
Led by Cardiac Success · Updated on 2025-02-28
20
Participants Needed
5
Research Sites
332 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vsling™ I: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Left ventricular end diastolic diameter greater than or equal to 55mm
- Ejection fraction between 20% and 40%
- Functional mitral regurgitation grade 2+ (mild) or less
- End-systolic interpapillary muscle distance 20mm or greater
- New York Heart Association class II to IVa
- Cardiomyopathy of ischemic or non-ischemic origins
- Able to understand the study and provide written informed consent
You will not qualify if you...
- Structural mitral valve lesions (chordal or leaflet damage)
- Ventricular tachycardia or ventricular fibrillation within 6 months prior to study
- Prior mitral valve repair or replacement
- ICD, CRT, or pacemaker leads implanted within 3 months prior to study
- Signs of cardiogenic shock within 30 days prior to study
- Anatomy preventing safe catheter passage for Vsling17 implantation
- Severe aortic stenosis
- Severe, massive, or torrential tricuspid regurgitation needing repair
- Fixed pulmonary hypertension with systolic pressure over 70 mmHg unresponsive to treatment
- ST elevation myocardial infarction within 30 days prior to study
- Congenital heart disease except PFO, PDA, or ASD
- Heart failure due to amyloid or restrictive cardiomyopathies
- Chronic renal insufficiency with creatinine 3.0 mg/dL or higher or on dialysis
- Any invasive cardiac procedure within 30 days prior to study
- Cardiac surgery within 3 months prior to study
- Stroke within 90 days prior to study
- Platelet count below 100,000/mm3 or above 750,000/mm3
- Body temperature above 386C within 3 days prior to procedure
- Bleeding disorders or increased clotting risk
- Active peptic ulcer or gastrointestinal bleeding within 90 days
- Contraindication to anticoagulants or antiplatelet drugs
- Allergy to stainless steel, nickel, titanium, or contrast agents that cannot be managed
- Allergy or contraindication to medications used in the procedure
- Participation in another investigational drug or device study interfering with this study
- Conditions limiting life expectancy to less than 12 months
- Conditions limiting ability to comply with study or affecting study integrity
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Shamir Medical Center
Be’er Ya‘aqov, Israel
Not Yet Recruiting
2
Rambam Medical Center
Haifa, Israel
Actively Recruiting
3
Hadassah Medical Center
Jerusalem, Israel
Not Yet Recruiting
4
Rabin Medical Center
Petah Tikva, Israel
Not Yet Recruiting
5
Tzafon Medical Center
Poria – Neve Oved, Israel
Actively Recruiting
Research Team
T
Tami Abudi, +972
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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