Heart Failure Clinical Trial
Official title:
A Multi-center, National, Open Label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP™ System, for Wirelessly Measuring and Monitoring Left Atrial Pressure (Lap) in Patients With Advanced CHF
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.
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 subjects Heart Failure. 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 their healthcare provider (HCP). Freedom from study (Device and/or system) related Major Adverse Cardiac and Neurological Events (MACNE as defined in the protocol) up to six months post-procedure, as adjudicated by the independent Clinical Events Committee. ;
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