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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00893828
First received: May 5, 2009
Last updated: March 3, 2014
Last verified: March 2014

May 5, 2009
March 3, 2014
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00893828 on ClinicalTrials.gov 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.

Not Provided
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
Not Provided
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00893828
Rev. B, 29-Sep-08
Yes
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Uta C Hoppe, Prof. Dr. University of Cologne
Boston Scientific Corporation
March 2014

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