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Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal (PAPIRUS III) (PAPIRUSIII)

This study has been completed.
Information provided by (Responsible Party):
Boston Scientific Corporation Identifier:
First received: May 5, 2009
Last updated: February 16, 2017
Last verified: February 2017

May 5, 2009
February 16, 2017
March 2009
September 2011   (Final data collection date for primary outcome measure)
Continue detailed data collection of pressure readings from patients implanted with a RemonCHF device. [ Time Frame: 24 months ]
Same as current
Complete list of historical versions of study NCT00893828 on Archive Site
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Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal (PAPIRUS III)
Monitoring Pulmonary Artery Pressure by Implanted Device Responding to Ultrasonic Signal
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.
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.
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   None Retained
Whole Blood
Non-Probability Sample
Patients previously implanted with a RemonCHF device
Heart Failure
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2017
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Rev. B, 29-Sep-08
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Boston Scientific Corporation
Boston Scientific Corporation
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Principal Investigator: Uta C Hoppe, Prof. Dr. University of Cologne
Boston Scientific Corporation
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP