NCT01162707

Wireless, Intermittent Monitoring of Right Heart Pressures in HF

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: CardioMEMS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• NYHA Class III Heart Failure

Interventions

Type	Name	Description
DEVICE	CardioMEMS HF Pressure Measurement System	Implant sensor into the left or right pulmonary artery. Measure pulmonary artery pressure

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-11-01
• Completion: 2012-09-01
• First posted: 2010-07-15
• Last updated: 2015-01-19

Locations

4 sites across 1 country: United States