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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
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

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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014