Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients with Heart Failure

NCT06002386 | Not Yet Recruiting

• 1 other identifier: CL-9022
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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

HFrEF - Heart Failure with Reduced Ejection Fraction

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 device

EXPERIMENTAL

Vsling device implantation

Device: Vsling

Interventions

Vsling DEVICE

Implantable ventricular repair device

Vsling device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥ 18 and \< 85 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
• 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
• Known allergy to stainless steel, nickel, titanium or contrast agents that cannot be adequately pre-medicated

Sponsors & Collaborators

• Cardiac Success: lead

Central Study Contacts

Iris Yadin-Herling

CONTACT

972546633352; iris.yh@cardiacsuccess.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 21, 2023
• Study Start: August 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share