NCT00604903

Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal

Remon CHF Medical Device Clinical Investigation PAPIRUS II: Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate and document appropriate clinical safety and performance of the Remon CHF Implantable Pressure Sensor including the corresponding delivery system, the Remon CHF Home Unit, the Remon CHF Clinic System devices and associated application software. It is a small clinical trial to determine the feasibility of the device. The primary outcome measure relates to feasibility and not to health outcomes.

Detailed description

This study was a prospective feasibility, non-randomised, singlearm, multi-centre, interventional clinical investigation performed at 4 international sites. Patients were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system. Measurements were taken with the Remon CHF Home Unit and the Remon CHF Clinic System. Follow-up visits took place at one, three and six months after implant. Per protocol, a minimum of 30 patients was required to demonstrate safety of the device. The study was conducted in accordance with ISO 14155:2003 (parts I and II), the Declaration of Helsinki and all applicable local and national regulations in the countries of submission.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Implant of Pressure sensor.	Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.

Timeline

• Start date: 2006-08-23
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-01-30
• Last updated: 2017-02-17