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

NCT06002386•Cardiac Success

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age≥ 18 and \< 85 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. End-systolic Interpapillary muscle distance ≥ 20mm
•6. NYHA class II-IVa
•7. Cardiomyopathy of ischemic or non-ischemic origins
•8. Understands the nature of the study and procedure and able to provide written informed consent

Exclusion Criteria

•1. Any evidence of structural (chordal or leaflet) mitral lesions
•2. Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion in this study
•3. Prior mitral valve repair or replacement
•4. ICD/CRT/cardiac pacemaker leads implanted within 3 months prior to inclusion in this study
•5. Clinical signs of cardiogenic shock within 30 days prior to inclusion in this study
•6. Anatomy that, in the opinion of the interventionalist, prevents safe passage of the Vsling™ catheter(s).
•7. Severe aortic stenosis
•8. Severe, massive, or torrential tricuspid regurgitation requiring surgical or transcatheter repair
•9. Known fixed pulmonary hypertension with PA systolic pressure \>70 mmHg not responsive to vasodilator therapy
•10. ST segment elevation myocardial infarction within 30 days prior to inclusion in this study
+17 more criteria

Key Dates

Start Date

August 1, 2025

Primary Completion Date

March 1, 2026

Completion Date

December 1, 2029

Last Updated

January 3, 2025

Enrollment

ESTIMATED participants

Conditions

HFrEF - Heart Failure with Reduced Ejection Fraction

Interventions

Vsling

DEVICE

Contacts

Iris Yadin-Herling

CONTACT

972546633352 iris.yh@cardiacsuccess.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Effect of Vericiguat on cardiAc Remodeling in Patients With Heart faiLure and Reduced Ejection fractioN (HFrEF): A Prospective sTudy usIng NOvel Echocardiographic Imaging Techniques (VALENTINO)

ALP-1 Continuous Intravenous Infusion to Maintain Clinical Stability in Advanced Heart Failure

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