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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
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Heart Failure

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    January 4, 2008
    Last Updated
    February 16, 2017
    Sponsor
    Boston Scientific Corporation
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    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

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    Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal

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