This trial has been completed.

Condition heart failure
Sponsor Boston Scientific Corporation
Start date March 2009
End date September 2011
Trial size 18 participants
Trial identifier NCT00893828, Rev. B, 29-Sep-08


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Continue detailed data collection of pressure readings from patients implanted with a RemonCHF device.
time frame: 24 months

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

Official title Monitoring Pulmonary Artery Pressure by Implanted Device Responding to Ultrasonic Signal
Principal investigator Uta C Hoppe, Prof. Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.