Validation of CardioMEMS HF System Cardiac Output Algorithm IDE

Heart Failure Clinical Trial

— VICTOR  

Official title:

Validation of CardioMEMS HF System Cardiac Output Algorithm IDE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05428384
• Other study ID #: ABT-CIP-10448
• Status: Completed
• Start date: August 31, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: June 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Output, High
• Heart Failure

Intervention

Device:
• MRI/ CardioMEMS comparison
Each subject will have CardioMEMS readings paired with MRI scans

Locations

Country	Name	City	State
United States	Piedmont Augusta Hospital	Augusta	Georgia
United States	Austin Heart	Austin	Texas
United States	Kansas University Medical Center	Kansas City	Kansas
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	St. Francis Hospital	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Ascension Providence Hospital	Southfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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