Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pressure Measurement System | Experimental | CardioMEMS HF Pressure Measurement System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioMEMS HF Pressure Measurement System | Device | Implant sensor into the left or right pulmonary artery. Measure pulmonary artery pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to evaluate the wireless monitoring of pulmonary artery pressure using the CardioMEMS HF Pressure Measurement System in adult subjects with Class III Heart Failure. | The trial will demonstrate that the CardioMEMS Sensor can be positioned in the right or left pulmonary artery, and the Sensor pulmonary artery pressure measurements correlate to standardized methods of intra-cardiac pressure measurements immediately after deployment of the sensor and at the 60 day follow-up visit. Safety is assessed by monitoring the occurrence of adverse events. | after implant of the sensor and at 60 day visit |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the capability of the CardioMEMS HF System to obtain the pressure measurement from the Sensor and transmit the pulmonary artery pressure data to a secure database. | after deployment of the sensor and at 60 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piedmont Hospital | Atlanta | Georgia | 30313 | United States | ||
| Ohio State University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Columbus |
| Ohio |
| 43085 |
| United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | United States |
| St Thomas Hospital | Nashville | Tennessee | 37201 | United States |