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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

January 4, 2008
February 1, 2012
August 2006
February 2009   (final data collection date for primary outcome measure)
Serious adverse events related to implantation or the device. [ Time Frame: 18 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00604903 on ClinicalTrials.gov Archive Site
Device accuracy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal
Not Provided

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

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Heart Failure
Device: Remon ImPressure implantable pulmonary artery pressure monitor
Remon ImPressure implantable pulmonary artery pressure monitor responding to ultrasonic signal.
Experimental: 1
Intervention: Device: Remon ImPressure implantable pulmonary artery pressure monitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00604903
PAPIRUS II
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Horst Sievert, M.D. CardioVascular Center Frankfurt, Seckbacher
Boston Scientific Corporation
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP