Status:
COMPLETED
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal (PAPIRUS III)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
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 physi...
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00893828
Start Date
March 1 2009
End Date
January 1 2017
Last Update
February 17 2017
Active Locations (1)
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1
University of Cologne
Cologne, Germany