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

Boston Scientific

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT00893828

Rev. B, 29-Sep-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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