CardioMEMS HF System OUS Post Market Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Abbott Medical Devices
- Enrollment
- 321
- Locations
- 5
- Primary Endpoint
- Freedom From Device/System Related Complications
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent obtained from subject
- •≥ 18 years of age
- •Diagnosis of NYHA Class III Heart Failure
- •At least 1 HF hospitalization within 12 months of Baseline visit
- •Subjects with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB.
- •Subjects with a BMI ≤
- •Subjects with BMI \>35 will require their chest circumference to be measured at the axillary level, if \> 65 inches the patient will not be eligible for the study.
- •Subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the RHC)
- •Subjects willing and able to comply with the follow-up requirements of the study
Exclusion Criteria
- •Subjects with an active infection
- •Subjects with history of recurrent (\> 1) pulmonary embolism or deep vein thrombosis
- •Subjects who, in the Investigator's opinion, are unable to tolerate a right heart catheterization
- •Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of Baseline Visit
- •Subjects with Cardiac Resynchronization Device (CRT) implanted \< 3 months prior to enrollment
- •Subjects with a Glomerular Filtration Rate (GFR) \< 25 ml/min (obtained within 2 weeks of the baseline visit) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
- •Subjects with congenital heart disease or mechanical right heart valve(s)
- •Subjects likely to undergo heart transplantation or VAD within 6 months of baseline visit
- •Subjects with known coagulation disorders
- •Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel (not applicable for subjects taking anti-coagulation therapy or other approved anti-platelets therapy).
Outcomes
Primary Outcomes
Freedom From Device/System Related Complications
Time Frame: Two year
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.
Freedom From Pressure Sensor Failure.
Time Frame: Two year
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.
Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment.
Time Frame: One year
HFH events at 1 year versus the HFH events in the year prior to enrollment