The purpose of this Post Market Study (PMS) is to evaluate the use of the CardioMEMS HF System in patients with New York Heart Association (NYHA) Class III Heart Failure in a commercial setting.
Study Type
OBSERVATIONAL
Enrollment
321
The Prince Charles Hospital
Chermside, Queensland, Australia
CHR Citadelle
Liège, Belgium
Rigshospitalet
Copenhagen, Denmark
CHRU de Lille
Lille, France
Royal Bromptom Hospital
London, United Kingdom
Freedom From Device/System Related Complications
A device/System related complication (DSRC) is an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: 1) is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); 2) results in death of the subject; 3) results in the explant of the device.
Time frame: Two year
Freedom From Pressure Sensor Failure.
A sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics.
Time frame: Two year
Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment.
HFH events at 1 year versus the HFH events in the year prior to enrollment
Time frame: One year
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