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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
May 5, 2009
May 6, 2009
February 17, 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 ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:
Whole Blood
Non-Probability Sample
Patients previously implanted with a RemonCHF device
Heart Failure
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
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)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00893828
Rev. B, 29-Sep-08
Yes
Not Provided
Plan to Share IPD: Undecided
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Uta C Hoppe, Prof. Dr. University of Cologne
Boston Scientific Corporation
February 2017