Status:
COMPLETED
CardioMEMS HF System Post Approval Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Left-Sided Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.
Detailed Description
The primary objective of this study is to demonstrate the safety and to report clinical performance of the CardioMEMS™ HF System in real world setting. Prospective, non-randomized, open-label, multi-...
Eligibility Criteria
Inclusion
- Diagnosis of NYHA class III heart failure
- At least 1 heart failure hospitalization within previous 12 months
- Patients 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 patient is intolerant to beta blockers, ACE-I or ARB
- BMI ≤ 35. Patients 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.
- Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)
Exclusion
- Active infection
- History of recurrent (\> 1) pulmonary embolism or deep vein thrombosis
- Inability to tolerate a right heart catheterization
- A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
- Cardiac resynchronization device (CRT) implanted within previous 3 months
- Glomerular Filtration Rate (GFR) \< 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
- Congenital heart disease or mechanical right heart valve
- Likely to undergo heart transplantation or VAD within the next 6 months
- Known coagulation disorders
- Hypersensitivity or allergy to aspirin, and/or clopidogrel
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 11 2019
Estimated Enrollment :
1214 Patients enrolled
Trial Details
Trial ID
NCT02279888
Start Date
January 1 2015
End Date
October 11 2019
Last Update
April 17 2024
Active Locations (1)
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1
West Virginia Heart Institute
Morgantown, West Virginia, United States, 26505