Evaluation of the Vsling Device for Ventricular Repair in Adults with Heart Failure and Reduced Ejection Fraction

What this Trial Is About

Researchers are evaluating the feasibility, initial safety, and performance of the Vsling device in patients with heart failure who have a reduced left ventricular ejection fraction and ventricular dilation. This Phase 2, multi-center, open-label clinical study focuses on patients with heart failure and aims to assess how well the Vsling device works for ventricular repair. The study is sponsored by Cardiac Success and targets adults aged 18 years and older. Participants will receive the Vsling device implantation, an implantable ventricular repair device designed to support heart function. The study does not involve a control group or placebo. The treatment is delivered through the implantation procedure, and the trial will monitor participants primarily for serious adverse events related to the device within 30 days of implantation. During the study, participants will be closely monitored for safety and device performance. Assessments will include heart function evaluations and clinical status according to various heart failure classifications. Researchers will track device-related serious adverse events for 30 days post-implantation. The study will continue until April 2031, with participant involvement including follow-up visits to ensure safety and gather performance data.

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