Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who exhibit signs and symptoms of NYHA Class III or IV heart failure.
Patients who are able to visit the clinic frequently during the 6 months following implantation.
Patients who are willing and able to perform all follow-up procedures.

Exclusion criteria

Patients under the age of 18
Pregnant women or women that plan to get pregnant during the study.
Patients with, tricuspid or pulmonic stenosis, pulmonary stents, right sided mechanical heart valves
Contraindication to antiplatelet therapy (aspirin and clopidogrel)
Patients suffering from active infection (on antibiotic therapy)
Known intracardiac mass (right atrial or right ventricular)
Patients who have been implanted with a VAD
Patients who are candidates for listing for heart transplantation if it is deemed that they have a possibility of receiving a heart within the next 6 months
Patients that have lead implanted at the heart right side of the heart within the last 6 months
Patients with any terminal illness, or with a life expectancy of less than 6 months
Patients that are unable to lie flat for the duration of the procedure
Patients that are unable to operate the home unit (due to physical or mental constrain)
Patients after pneumonectomy
Patients treated with oral anticoagulants INR > 1.5 prior to catheterization
Patients with severe chronic renal failure (creatinine > 2.5 mg/dl)
Patients suffered from acute myocardial infarction within the three months prior the study
Patients that underwent open heart surgery within 4 weeks prior the study.

Treatment and study plan

Implant of Pressure sensor.

Device

Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.

Primary outcomes

Serious adverse events related to implantation or the device

Time frame: 6

Primary Device Safety Objective: Serious Adverse Device Effects rate during 6 months following implantation (device or delivery system related) and Implantation related Serious Adverse Events rate during 6 months following implantation

Secondary outcomes

Device accuracy

Time frame: 6 months

Compare accuracy of Remon Pressure Sensor with Millar catheter (invasive way of measuring pulmonary artery pressure).

Secondary end points included accuracy of the measured PA pressure, functionality of the system and evaluation of pressure readings at different postures.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: PAPIRUSII

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Jan 30, 2008
Registry last updated: Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed