Clinical trial NCT05428384: Validation of CardioMEMS HF System Cardiac Output Algorithm IDE
Official title: Validation of CardioMEMS HF System Cardiac Output Algorithm IDE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Cardiac Output
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2022-06-23
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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).


Eligibility criteria: Inclusion Criteria:

1. Subject is willing and able to provide written informed consent prior to any clinical investigation-related procedure.
2. Subject is implanted with the CardioMEMS Pulmonary Artery Sensor for a minimum of 3 months at time of consent.
3. Subject is ≥ 18 years of age.
4. 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
5. 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:

1. Subject will receive or is likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 6 months.
2. Subject was implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent.
3. Subject is pregnant or planning to become pregnant in the next 6 months.
4. Subject is enrolled into another trial with an active treatment arm.
5. Subject has significant congenital heart disease that has not been repaired.
6. Subject is implanted with mechanical right heart valve(s).
7. Subject has unrepaired severe valvular disease.
8. Subject has an anticipated life expectancy of \< 6 months.
9. 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).
10. 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.
11. Subject has any condition that, in the opinion of the Investigator, would not allow for utilization of the CardioMEMS HF System to manage the subject using information gained from hemodynamic measurements to adjust medications, including the presence of unexpectedly severe pulmonary hypertension (e.g., trans-pulmonary gradient \>15) at implant Right Heart Catheterization, a history of non-compliance, or any condition that would preclude ability to obtain CardioMEMS Pulmonary Artery Sensor readings and paired cardiac Magnetic Resonance Imaging data from being collected.
12. Subjects who, in the opinion of the investigator, are at-risk for serious adverse reaction to Dobutamine (ex. subjects with idiopathic hypertrophic subaortic stenosis and subjects who have shown previous manifestations of hypersensitivity to Dobutamine) should be excluded from the study.

Primary outcomes:
measure: Cardiac output estimation
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Piedmont Augusta Hospital
state: Georgia
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Southfield
country: United States
facility: Ascension Providence Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: New York
country: United States
facility: St. Francis Hospital
state: New York
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
Study officials:
References: