V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance CHF

Heart Failure Clinical Trial

Official title: A Multi-center, Open-label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP™ System

Status Recruiting

Clinical Trial Summary

The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association (NYHA) functional class II and III HF, irrespective of left ventricular ejection fraction.

Clinical Trial Description

The trial is designed to demonstrate that the V-LAP™ implant can be positioned in the interatrial septum.

The V- LAP™ System is intended for wirelessly measuring and monitoring LAP. The V-LAP™ System is indicated for subjects with chronic symptomatic ACC/AHA Stage C.

Pressure-guided medical management of study participants, with the goal of reducing hospitalizations and improving quality of life, will be implemented using a physician-directed patient self-management approach.

V-LAP-PSM (Patient Self-management), Patient Guidance Application is a smartphone application that guides the patient on how to self-adjust the treatment, according to physician prescription, and when to approach the study investigator.

Safety will be monitored by the occurrence of adverse events throughout the trial. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT05712824
• Study type: Interventional
• Source: Vectorious Medical Technologies Ltd.
• Contact: Dedi Erdheim
• Phone: +972 72 342 5462
• Email: dedi@vectoriousmedtech.com
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2021
• Completion date: December 2027