Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal (PAPIRUSII)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implant of Pressure sensor.
Sponsored by

About this trial
This is an interventional device feasibility trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients implanted with Pressure Sensor
Arm Description
Implant of Pressure sensor. These are patients, who were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00604903
First Posted
January 4, 2008
Last Updated
February 16, 2017
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00604903
Brief Title
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal
Acronym
PAPIRUSII
Official Title
Remon CHF Medical Device Clinical Investigation PAPIRUS II: Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 23, 2006 (Actual)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
No masking
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients implanted with Pressure Sensor
Arm Type
Experimental
Arm Description
Implant of Pressure sensor. These are patients, who were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system.
Intervention Type
Device
Intervention Name(s)
Implant of Pressure sensor.
Intervention Description
Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.
Primary Outcome Measure Information:
Title
Serious adverse events related to implantation or the device
Description
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
Time Frame
6
Secondary Outcome Measure Information:
Title
Device accuracy
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horst Sievert, M.D.
Organizational Affiliation
CardioVascular Center Frankfurt, Seckbacher
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19196733
Citation
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.
Results Reference
result
Learn more about this trial
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal
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