Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal (PAPIRUSII)
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
No maskingPrimary Purpose: Device Feasibility
|Official Title:||Remon CHF Medical Device Clinical Investigation PAPIRUS II: Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal|
- Serious adverse events related to implantation or the device [ Time Frame: 6 ]Primary Device Safety Objective: Serious Adverse Device Effects rate during 6 months following implantation (device or delivery system related) and Implantation related Serious Adverse Events rate during 6 months following implantation
- Device accuracy [ Time Frame: 6 months ]
Compare accuracy of Remon Pressure Sensor with Millar catheter (invasive way of measuring pulmonary artery pressure).
Secondary end points included accuracy of the measured PA pressure, functionality of the system and evaluation of pressure readings at different postures.
|Actual Study Start Date:||August 23, 2006|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: Patients implanted with Pressure Sensor
Implant of Pressure sensor. These are patients, who were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system.
Device: Implant of Pressure sensor.
Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.
This study was a prospective feasibility, non-randomised, singlearm, multi-centre, interventional clinical investigation performed at 4 international sites. Patients were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system. Measurements were taken with the Remon CHF Home Unit and the Remon CHF Clinic System. Follow-up visits took place at one, three and six months after implant.
Per protocol, a minimum of 30 patients was required to demonstrate safety of the device.
The study was conducted in accordance with ISO 14155:2003 (parts I and II), the Declaration of Helsinki and all applicable local and national regulations in the countries of submission.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604903
|Principal Investigator:||Horst Sievert, M.D.||CardioVascular Center Frankfurt, Seckbacher|