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

Remon CHF Medical Device Clinical Investigation PAPIRUS II: 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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Implant of Pressure sensor.

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Patients under the age of 18
2. Pregnant women or women that plan to get pregnant during the study.
3. Patients with, tricuspid or pulmonic stenosis, pulmonary stents, right sided mechanical heart valves
4. Contraindication to antiplatelet therapy (aspirin and clopidogrel)
5. Patients suffering from active infection (on antibiotic therapy)
6. Known intracardiac mass (right atrial or right ventricular)
7. Patients who have been implanted with a VAD
8. 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
9. Patients that have lead implanted at the heart right side of the heart within the last 6 months
10. Patients with any terminal illness, or with a life expectancy of less than 6 months
11. Patients that are unable to lie flat for the duration of the procedure
12. Patients that are unable to operate the home unit (due to physical or mental constrain)
13. Patients after pneumonectomy
14. Patients treated with oral anticoagulants INR > 1.5 prior to catheterization
15. Patients with severe chronic renal failure (creatinine > 2.5 mg/dl)
16. Patients suffered from acute myocardial infarction within the three months prior the study
17. Patients that underwent open heart surgery within 4 weeks prior the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients implanted with Pressure Sensor; Implant of Pressure sensor. These are patients, who were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system.	Device: Implant of Pressure sensor.; Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events related to implantation or the device	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	6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device accuracy	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.	6 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Horst Sievert, M.D., CardioVascular Center Frankfurt, Seckbacher

Publications and helpful links

General Publications

• Hoppe UC, Vanderheyden M, Sievert H, Brandt MC, Tobar R, Wijns W, Rozenman Y. Chronic monitoring of pulmonary artery pressure in patients with severe heart failure: multicentre experience of the monitoring Pulmonary Artery Pressure by Implantable device Responding to Ultrasonic Signal (PAPIRUS) II study. Heart. 2009 Jul;95(13):1091-7. doi: 10.1136/hrt.2008.153486. Epub 2009 Feb 5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 23, 2006
• Primary Completion (ACTUAL): February 1, 2009
• Study Completion (ACTUAL): February 1, 2009

Study Registration Dates

• First Submitted: January 4, 2008
• First Submitted That Met QC Criteria: January 29, 2008
• First Posted (ESTIMATE): January 30, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PAPIRUS II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No