Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Implant of Pressure sensor.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients implanted with Pressure Sensor<br>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.<br>* Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.<br>|

What is the study measuring?
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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 |