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OpenTrials
Completed

NCT Number: NCT00893828

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cologne

Cologne, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Continue detailed data collection of pressure readings from patients implanted with a RemonCHF device.

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Monitoring Pulmonary Artery Pressure by Implanted Device Responding to Ultrasonic Signal

Acronym: PAPIRUSIII

Important dates

Study start
2009
Primary completion
2011
Study completion
2017
First posted
May 6, 2009
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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