Heart FailureVICTORNCT05428384
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE
An observational study of Heart Failure and Cardiac Output, run by Abbott Medical Devices at 8 sites in United States.
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™… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Output
- What is being tested?
- MRI/ CardioMEMS comparison
- Type of treatment
- Medical device
- How many people
- 89 participants
- Where
- 8 sitesUnited States
- Study dates
- 31 Aug 2022to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- 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.
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Piedmont Augusta Hospital
Augusta, Georgia, 30901
Austin Heart
Austin, Texas, 78756
Kansas University Medical Center
Kansas City, Kansas, 13810
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
St. Francis Hospital
New York, New York, 25301
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Sanford USD Medical Center
Sioux Falls, South Dakota, 57105
Ascension Providence Hospital
Southfield, Michigan, 48075
About this study
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).
- Conditions
- Heart Failure, Cardiac Output
- Being tested
- MRI/ CardioMEMS comparison
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI/ CardioMEMS comparisonDevice
Each subject will have CardioMEMS readings paired with MRI scans
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Participants | Each participant will have paired CardioMEMS and cardiac MRI measurements at both baseline and 3-month follow-up visits. Receives: Device: MRI/ CardioMEMS comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start31 Aug 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428384
- Sponsor's protocol ID
- ABT-CIP-10448
- Acronym
- VICTOR
- Status last verified
- Feb 2025
- First submitted
- 17 Jun 2022
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of CardioMEMS HF System Cardiac Output Algorithm IDE
- ClinicalTrials.gov ID
- NCT05428384
- Acronym / sponsor ID
- VICTOR / ABT-CIP-10448
- Conditions
- Heart Failure, Cardiac Output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Participants | – | Device: MRI/ CardioMEMS comparisonEach participant will have paired CardioMEMS and cardiac MRI measurements at both baseline and 3-month follow-up visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI/ CardioMEMS comparisonEach subject will have CardioMEMS readings paired with MRI scans | Device | Enrolled Participants |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiac Output, run by Abbott Medical Devices at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output estimation (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.