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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00893828
First Posted: May 6, 2009
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
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
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring Pulmonary Artery Pressure by Implanted Device Responding to Ultrasonic Signal

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Continue detailed data collection of pressure readings from patients implanted with a RemonCHF device. [ Time Frame: 24 months ]

Biospecimen Retention:   None Retained
Whole Blood

Enrollment: 18
Actual Study Start Date: March 2009
Study Completion Date: January 2017
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients previously implanted with a RemonCHF device
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893828


Locations
Germany
University of Cologne
Cologne, Germany
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Uta C Hoppe, Prof. Dr. University of Cologne
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00893828     History of Changes
Other Study ID Numbers: Rev. B, 29-Sep-08
First Submitted: May 5, 2009
First Posted: May 6, 2009
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases