Validation of CardioMEMS HF System Cardiac Output Algorithm IDE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Abbott Medical Devices
- Enrollment
- 89
- Locations
- 8
- Primary Endpoint
- Cardiac output estimation
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
The investigation will enroll subjects who have been previously implanted with the CardioMEMS™ Pulmonary Artery Sensor. This clinical investigation is twofold; in the first phase (development phase) data collected will be used to complete development of an algorithm that can estimate cardiac output from CardioMEMS™ Heart Failure (HF) System readings. The second phase (validation phase) of this clinical investigation is intended to compare the Cardiac Output estimate from CardioMEMS HF System to Cardiac Output estimates from Cardiac Magnetic Resonance Imaging (reference standard).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is willing and able to provide written informed consent prior to any clinical investigation-related procedure.
- •Subject is implanted with the CardioMEMS Pulmonary Artery Sensor for a minimum of 3 months at time of consent.
- •Subject is ≥ 18 years of age.
- •Subject is willing and able to undergo several cardiac Magnetic Resonance Imaging scans. This is including but not limited to:
- •Subject must have all Magnetic Resonance Imaging compatible devices
- •Subject must be able to hold their breath during imaging
- •Subject must be free of all metal bodies, fragments, or implants that would prohibit Magnetic Resonance imaging
- •Subject is willing and able to upload Pulmonary Artery pressure information (i.e., take daily CardioMEMS readings and have their hemodynamic information collected at study visits) and comply with the follow-up requirements.
Exclusion Criteria
- •Subject will receive or is likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 6 months.
- •Subject was implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent.
- •Subject is pregnant or planning to become pregnant in the next 6 months.
- •Subject is enrolled into another trial with an active treatment arm.
- •Subject has significant congenital heart disease that has not been repaired.
- •Subject is implanted with mechanical right heart valve(s).
- •Subject has unrepaired severe valvular disease.
- •Subject has an anticipated life expectancy of \< 6 months.
- •Subject has an active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures (blood, sputum, or urine).
- •Subject has had a major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent.
Outcomes
Primary Outcomes
Cardiac output estimation
Time Frame: 18 months
The primary outcome of this clinical investigation is to estimate Cardiac Output from CardioMEMS HF System data. The estimated Cardiac Output will be evaluated for agreement between the CardioMEMS HF System-derived Cardiac Output and the Cardiac Output values from cardiac Magnetic Resonance Imaging in patients with the CardioMEMS HF System