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The investigation will enroll subjects who have been previously implanted with the CardioMEMSâ„¢ 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 CardioMEMSâ„¢ 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enrolled Participants | Each participant will have paired CardioMEMS and cardiac MRI measurements at both baseline and 3-month follow-up visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI/ CardioMEMS comparison | Device | Each subject will have CardioMEMS readings paired with MRI scans |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac output estimation | 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 | 18 months |
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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 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:
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This clinical investigation will enroll subjects of all genders who are ≥ 18 years of age from the CardioMEMS HF System patient population. The patient population for this clinical trial consists of potential subjects who have had a CardioMEMS PA Sensor previously implanted for a minimum of 3 months at time of consent.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piedmont Augusta Hospital | Augusta | Georgia | 30901 | United States | ||
| Kansas University Medical Center |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2022 | Jan 29, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2022 | Mar 24, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Kansas City |
| Kansas |
| 13810 |
| United States |
| Ascension Providence Hospital | Southfield | Michigan | 48075 | United States |
| University of Minnesota Medical Center Fairview | Minneapolis | Minnesota | 55455 | United States |
| St. Francis Hospital | New York | New York | 25301 | United States |
| Sanford USD Medical Center | Sioux Falls | South Dakota | 57105 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |