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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00604903
First received: January 4, 2008
Last updated: February 16, 2017
Last verified: February 2012
  Purpose
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.

Condition Intervention
Heart Failure
Device: Implant of Pressure sensor.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Masking Description:
No masking
Primary Purpose: Device Feasibility
Official Title: Remon CHF Medical Device Clinical Investigation PAPIRUS II: Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.



Enrollment: 42
Actual Study Start Date: August 23, 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604903

Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Horst Sievert, M.D. CardioVascular Center Frankfurt, Seckbacher
  More Information

Publications:
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00604903     History of Changes
Other Study ID Numbers: PAPIRUS II 
Study First Received: January 4, 2008
Last Updated: February 16, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 24, 2017