NYHA Class III Heart Failure Clinical Trial
Official title:
A Multi-Center, Non-Randomized, Prospective Trial to Evaluate the Safety and Feasibility of Wireless, Intermittent Monitoring of Right Heart Pressures in Adult Heart Failure Subjects
The purpose of the trial is to evaluate the wireless monitoring of pulmonary artery pressure using the CardioMEMS HF Pressure Measurement System in adult subjects with NYHA Class III Heart Failure.
The trial is designed to demonstrate that the CardioMEMS Sensor can be positioned in the right or left pulmonary artery, and that Sensor pressure measurements correlate to standardized methods of intra-cardiac pressure measurements post-sensor implant and at the 60 day visit. Safety will be monitored by the occurrence of adverse events throughout the trial. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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