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

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00893828
Collaborator
(none)
18
Enrollment
1
Location
94.1
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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 physiological changes during activities of daily living and protocol defined tests.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    18 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Monitoring Pulmonary Artery Pressure by Implanted Device Responding to Ultrasonic Signal
    Actual Study Start Date :
    Mar 1, 2009
    Actual Primary Completion Date :
    Sep 1, 2011
    Actual Study Completion Date :
    Jan 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Continue detailed data collection of pressure readings from patients implanted with a RemonCHF device. [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Cologne Cologne Germany

    Sponsors and Collaborators

    • Boston Scientific Corporation

    Investigators

    • Principal Investigator: Uta C Hoppe, Prof. Dr., University of Cologne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT00893828
    Other Study ID Numbers:
    • Rev. B, 29-Sep-08
    First Posted:
    May 6, 2009
    Last Update Posted:
    Feb 17, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Feb 17, 2017