Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal

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 1, 2012
Last verified: February 2012
  Purpose

This study will evaluate an implantable pulmonary artery pressure sensor in patients with heart failure.


Condition Intervention
Heart Failure
Device: Remon ImPressure implantable pulmonary artery pressure monitor

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Serious adverse events related to implantation or the device. [ Time Frame: 18 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Device accuracy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Remon ImPressure implantable pulmonary artery pressure monitor
Remon ImPressure implantable pulmonary artery pressure monitor responding to ultrasonic signal.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • Patients who are pregnant or plan to get pregnant during the study.
  • Patients with tricuspid or pulmonary stenosis.
  • Patients with pulmonary stents or right-sided mechanical heart valve(s).
  • Patients who are contraindicated for antiplatelet therapy (aspirin and clopidogrel).
  • Patients suffering from active infection on antibiotic therapy.
  • Patients with known intracardiac mass (right atrial or right ventricular).
  • Patients who are candidates for listing for heart transplant if it is deemed that they may receive a heart within the next 6 months.
  • Patients who have had an intracardiac lead implanted in the right side of the heart in 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 constraint.
  • 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 with acute MI within 3 months prior to study.
  • Patients that underwent open heart surgery within 4 weeks prior to the study.
  • Both.
  Contacts and Locations
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

No publications provided

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 1, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014