Validation of CardioMEMS HF System Cardiac Output Algorithm IDE

Completed

• Conditions: Heart Failure; Cardiac Output
• Interventions: Device: MRI/ CardioMEMS comparison

• Registration Number: NCT05428384
• Lead Sponsor: Abbott Medical Devices

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Study Start: 2022-08-31
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mono arm	MRI/ CardioMEMS comparison	Each subject will have at baseline and at 3 month follow-up CardioMEMS readings paired with cardiac MRI scans and measurements completed for each subject will be under nominally the same conditions.

Primary Outcome Measures

Name	Time	Method
Cardiac output estimation	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

Trial Locations

Locations (8)

Piedmont Augusta Hospital; 🇺🇸 Augusta, Georgia, United States

Ascension Providence Hospital; 🇺🇸 Southfield, Michigan, United States

University of Minnesota Medical Center Fairview; 🇺🇸 Minneapolis, Minnesota, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States

Sanford USD Medical Center; 🇺🇸 Sioux Falls, South Dakota, United States

Austin Heart; 🇺🇸 Austin, Texas, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

St. Francis Hospital; 🇺🇸 New York, New York, United States