Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal

This study is ongoing, but not recruiting participants.

First Received: January 4, 2008 Last Updated: June 22, 2009 History of Changes

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00604903

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:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

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:

Estimated Enrollment:	40
Study Start Date:	August 2006
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: Remon ImPressure implantable pulmonary artery pressure monitor Remon ImPressure implantable pulmonary artery pressure monitor responding to ultrasonic signal.

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 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 recieve 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 Cardiac Rhythm Management ( Jeffrey Von Arx, Ph.D./Director, Technology Research )
Study ID Numbers:	PAPIRUS II
Study First Received:	January 4, 2008
Last Updated:	June 22, 2009
ClinicalTrials.gov Identifier:	NCT00604903 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009