Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal (PAPIRUS III)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Boston Scientific Corporation
First received: May 5, 2009
Last updated: March 3, 2014
Last verified: March 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Monitoring Pulmonary Artery Pressure by Implanted Device Responding to Ultrasonic Signal
Biospecimen Retention: None Retained
Primary Outcome Measures:
- Continue detailed data collection of pressure readings from patients implanted with a RemonCHF device. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients previously implanted with a RemonCHF device
- 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.
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00893828
|University of Cologne
|Cologne, Germany |
Boston Scientific Corporation
||Uta C Hoppe, Prof. Dr.
||University of Cologne
No publications provided
||Boston Scientific Corporation
History of Changes
|Other Study ID Numbers:
||Rev. B, 29-Sep-08
|Study First Received:
||May 5, 2009
||March 3, 2014
||Germany: Federal Institute for Drugs and Medical Devices
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 24, 2014