Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal (PAPIRUS III)
This trial has been completed.
|Sponsor||Boston Scientific Corporation|
|Start date||March 2009|
|End date||September 2011|
|Trial size||18 participants|
|Trial identifier||NCT00893828, Rev. B, 29-Sep-08|
The PAPIRUS III study will continue to follow patients initially enrolled in PAPIRUS II. Pressure readings from the investigational device will continue to be collected and will be correlated to physiological changes during activities of daily living and protocol defined tests.
Continue detailed data collection of pressure readings from patients implanted with a RemonCHF device.
time frame: 24 months
All participants at least 18 years old.
Inclusion Criteria: - Patient has been enrolled in the PAPIRUS II Study and has a RemonCHF pressure sensor implanted - Patient is willing and able to provide informed consent, participate in the Safety Follow-up Program and/or in the required tests associated with the clinical investigation (Core Study Program) at an approved clinical investigational center and at the intervals defined by the Clinical Investigational Plan. Exclusion Criteria: - Patient enrolled in PAPIRUS II but not implanted with a RemonCHF Pressure Sensor - Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study (with the exception of the PAPIRUS II Study). Each instance would be brought to the sponsor to determine eligibility. - Age < 18 years - Women of childbearing potential who are, or might be, pregnant at the time of the study
|Official title||Monitoring Pulmonary Artery Pressure by Implanted Device Responding to Ultrasonic Signal|
|Principal investigator||Uta C Hoppe, Prof. Dr.|
|Description||This is a small clinical trial to determine the feasibility of a device & to test prototype device, where the primary outcome measure relates to feasibility and not to health outcomes.|
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