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

NCT06851949 | Recruiting Phase 2

• 1 other identifier: CL-9003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Device 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

  30 Days

Study Arms (1)

Vsling

EXPERIMENTAL

Vsling Device implantation

Device: Vsling

Interventions

Vsling DEVICE

Implantable ventricular repair device

Vsling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any evidence of structural (chordal or leaflet) mitral lesions
• Prior mitral valve repair or replacement
• 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
• 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
• 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

Sponsors & Collaborators

• Cardiac Success: lead

Study Sites (5)

Shamir Medical Center

Be’er Ya‘aqov, Israel

NOT YET RECRUITING

Rambam Medical Center

Haifa, Israel

RECRUITING

Hadassah Medical Center

Jerusalem, Israel

NOT YET RECRUITING

Rabin Medical Center

Petah Tikva, Israel

NOT YET RECRUITING

Tzafon Medical Center

Poria – Neve Oved, Israel

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Tami Abudi, +972

CONTACT

+972 (52) 5989833; tami.a@cardiacsuccess.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: February 28, 2025
• Study Start: November 15, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): April 1, 2031
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

IL (5)