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

Completed

• Conditions: Heart Failure

• Registration Number: NCT00893828
• Lead Sponsor: Boston Scientific Corporation

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.

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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-05-05
• Study First Submitted QC: 2009-05-05
• Study First Posted: 2009-05-06
• Primary Completion: 2011-09
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Continue detailed data collection of pressure readings from patients implanted with a RemonCHF device.	24 months

Trial Locations

Locations (1)

University of Cologne; 🇩🇪 Cologne, Germany