Heart FailureNCT07730268
Vivio At-Home Study
A study testing Vivio measurement in people with Heart Failure, run by Ventric Health, LLC at 4 sites in United States.
Trial summary
The purpose of the study is to examine the Vivio System's ability to track heart failure status in subjects, and compare the Vivio System's measurements to CardioMEMS measurements. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Vivio measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Oct 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects over the age of 21.
- A CardioMEMS HF System implanted or scheduled to be implanted.
- 70% or more signal strength from CardioMEMS at the time of enrollment.
- Ability to successfully obtain a Vivio System measurement.
- Willing and able to participate in all study evaluations and allow access to medical records, including medical testing records up to 2 years after completion of the study.
- Ability to understand and sign informed consent.
Who cannot join
- Open skin lesions at the site of Vivio application / examination.
- Inability to obtain brachial artery blood pressure.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
MemorialCare Long Beach Medical Center
Long Beach, California, 90806
USC Keck School of Medicine
Los Angeles, California, 90033
Renown Regional Medical Center
Reno, Nevada, 89502
UC San Diego School of Medicine
San Diego, California, 92037
About this study
Official title: Evaluation of a Novel, Non-Invasive Approach to Estimating Pulmonary Artery Pressure as an Alternative Method for Tracking Heart Failure Status
The purpose of the study is to examine the Vivio System's ability to track heart failure status in subjects, and compare the Vivio System's measurements to CardioMEMS measurements. Heart failure, which is a form of heart disease, is a condition where the heart does not pump enough blood through the body, resulting in the body not getting the amount of oxygen and nutrients it needs. This research study will collect data using CardioMEMS and the Vivio System in subjects over the age of 21 with a currently implanted, or scheduled to be implanted, CardioMEMS device. This group of individuals will provide researchers with important data because the measurements of their health information can be used to determine if the Vivio is as effective at tracking heart failure status as CardioMEMS. This research study is designed to develop new knowledge, and does not provide a direct benefit to study subjects
Read the detailed description
This is a prospective, comparative study for the evaluation of the Vivio System in estimating pulmonary artery pressure (PAP) compared to CardioMEMS measuring PAP to track heart failure (HF) status. This study will recruit adult participants based on the inclusion and exclusion criteria. A total of up to 500 participants will be enrolled at up to 20 sites across the United States. Participants will take Vivio and CardioMEMS measurements 2-4 times per week for a minimum of 30 days and a maximum of 90 days, and these measurements will be used to determine the Vivio System's ability to assess the changes in PAP over time.
After obtaining informed consent, a participant's demographics, physical traits, past medical history, and current medications will be documented. Participants will undergo an echocardiogram if they have not had one in the past 30 days before study enrollment. The participant will then have a blood draw, complete a KCCQ-12 Questionnaire and secondary questionnaire, take one Vivio measurement, and will be oriented to the study schedule, and trained on how to take Vivio measurements. During the participant's study enrollment, one successful Vivio measurement will be taken after completing one CardioMEMS measurement. One additional Vivio measurement will be taken if the participant enrolls in the study before CardioMEMS implantation. These measurements will be collected 2-4 times per week at the discretion of the participant's physician. After completion of assigned measurements, the participant will return the study equipment and complete a final questionnaire.
The proposed study is conducted according to CFR 812.2 in particular with regard to the device labeling, research done only after IRB approval and informed consent (21 CFR 50), with monitoring of the study and records kept as required by 21 CFR 56.
- Conditions
- Heart Failure
- Being tested
- Vivio measurement
- Keywords
- Pulmonary artery pressure, Heart Failure, Vivio, Ventric, Non-Invasive, Diagnostic
- Medical subject headings
- Heart Failure, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivio measurementDiagnostic test
The Vivio measurement is taken after a CardioMEMS measurement
| Study group | Role | What they receive |
|---|---|---|
| Vivio comparison to CardioMEMS | Experimental | Observational comparison of Vivio measurements to CardioMEMS measurements Receives: Diagnostic Test: Vivio measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing Vivio measurements to CardioMEMS measurements over time
To assess the longitudinal agreement between non-invasive hemodynamic signals collected using the Vivio System and pulmonary artery pressure (PAP) measurements obtained via the CardioMEMS HF System.
Measured: From enrollment to the end of participation at 30-90 days
Secondary outcomes (4)
Assessment of KCCQ-12 Scores
To assess the association between the scores of the 12-question Kansas City Cardiomyopathy Questionnaire and the occurrence of heart failure hospitalization, the occurrence of HF-related events and/or all-cause mortality within 12 months after the conclusion of the Vivio/CardioMEMS monitoring period.
The Kansas City Cardiomyopathy Questionnaire uses a 0 to 100 scale, where higher scores indicate better health and a higher quality of life with fewer limitations due to heart failure: ≥ 75: Good to excellent health status 50-74: Fair to good health status 25-49: Poor to fair health status <25: Very poor health status
Measured: From time of enrollment to 12 months after completion of participant Vivio use
KCCQ-12 and Ventric HF Score Comparison
Evaluating the degree of agreement and/or divergence between the non-validated Ventric Heart Failure Pro Questionnaire and the validated 12-question Kansas City Cardiomyopathy Questionnaire in capturing symptom burden, functional status, and health-related quality of life over time.
The Kansas City Cardiomyopathy Questionnaire uses a 0 to 100 scale, where higher scores indicate better health and a higher quality of life with fewer limitations due to heart failure: ≥ 75: Good to excellent health status 50-74: Fair to good health status 25-49: Poor to fair health status <25: Very poor health status.
The Ventric Heart Failure Pro Questionnaire is a 12-question survey with a score range from 0-200 with a higher score indicating a higher risk of critical decompensation. The data from the study will be used to validate the questionnaire.
We will compare the two questionnaires and assess the agreement and/or divergence between the scores and patient related outcomes.
Measured: From time of enrollment to end of participation at 30-90 days
Assessment of Ventric HF Scores
Assessing the relationship between the Ventric Heart Failure Pro Questionnaire and the occurrence of HF-related events and/or hospitalization. The Ventric Heart Failure Pro Questionnaire is a 12 question survey with a score range from 0-200 with a higher score indicating a higher risk of critical decompensation. The data from the study will be used to validate the questionnaire.
Measured: From time of enrollment to end of participation at 30-90 days
Vivio and CardioMEMS measurements related to SAEs and other HF related events
Evaluating the degree of agreement and/or divergence between non-invasive hemodynamic signals collected using the Vivio System and pulmonary artery pressure (PAP) measurements obtained via the CardioMEMS HF System prior to hospitalization (length of stay 24 hours or more) with the primary reason for admission being acute decompensated heart failure and intravenous administration of diuretic therapy, or an unscheduled or unplanned emergency department visit, or hospital outpatient observation visit with intravenous administration of diuretic therapy, counted only if it does not result in an inpatient admission of 24 hours or more.
Measured: From time of enrollment to 2 years after completion of participant Vivio use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start20 Oct 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ventric Health, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730268
- Sponsor's protocol ID
- CP-0011
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 28 Jul 2026
- 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel, Non-Invasive Approach to Estimating Pulmonary Artery Pressure as an Alternative Method for Tracking Heart Failure Status
- ClinicalTrials.gov ID
- NCT07730268
- Acronym / sponsor ID
- CP-0011
- Conditions
- Heart Failure
- Keywords
- Pulmonary artery pressure, Heart Failure, Vivio, Ventric, Non-Invasive, Diagnostic
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ventric Health, LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Jul 2026 (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 purpose of the study is to examine the Vivio System's ability to track heart failure status in subjects, and compare the Vivio System's measurements to CardioMEMS measurements. Heart failure, which is a form of heart disease, is a condition where the heart does not pump enough blood through the body, resulting in the body not getting the amount of oxygen and nutrients it needs. This research study will collect data using CardioMEMS and the Vivio System in subjects over the age of 21 with a currently implanted, or scheduled to be implanted, CardioMEMS device. This group of individuals will provide researchers with important data because the measurements of their health information can be used to determine if the Vivio is as effective at tracking heart failure status as CardioMEMS. This research study is designed to develop new knowledge, and does not provide a direct benefit to study subjects
Detailed description
This is a prospective, comparative study for the evaluation of the Vivio System in estimating pulmonary artery pressure (PAP) compared to CardioMEMS measuring PAP to track heart failure (HF) status. This study will recruit adult participants based on the inclusion and exclusion criteria. A total of up to 500 participants will be enrolled at up to 20 sites across the United States. Participants will take Vivio and CardioMEMS measurements 2-4 times per week for a minimum of 30 days and a maximum of 90 days, and these measurements will be used to determine the Vivio System's ability to assess the changes in PAP over time.
After obtaining informed consent, a participant's demographics, physical traits, past medical history, and current medications will be documented. Participants will undergo an echocardiogram if they have not had one in the past 30 days before study enrollment. The participant will then have a blood draw, complete a KCCQ-12 Questionnaire and secondary questionnaire, take one Vivio measurement, and will be oriented to the study schedule, and trained on how to take Vivio measurements. During the participant's study enrollment, one successful Vivio measurement will be taken after completing one CardioMEMS measurement. One additional Vivio measurement will be taken if the participant enrolls in the study before CardioMEMS implantation. These measurements will be collected 2-4 times per week at the discretion of the participant's physician. After completion of assigned measurements, the participant will return the study equipment and complete a final questionnaire.
The proposed study is conducted according to CFR 812.2 in particular with regard to the device labeling, research done only after IRB approval and informed consent (21 CFR 50), with monitoring of the study and records kept as required by 21 CFR 56.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vivio comparison to CardioMEMS | Experimental | Diagnostic Test: Vivio measurementObservational comparison of Vivio measurements to CardioMEMS measurements |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult subjects over the age of 21.
- A CardioMEMS HF System implanted or scheduled to be implanted.
- 70% or more signal strength from CardioMEMS at the time of enrollment.
- Ability to successfully obtain a Vivio System measurement.
- Willing and able to participate in all study evaluations and allow access to medical records, including medical testing records up to 2 years after completion of the study.
Key exclusion criteria (2 listed)
- Open skin lesions at the site of Vivio application / examination.
- Inability to obtain brachial artery blood pressure.
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 |
|---|---|---|
| Vivio measurementThe Vivio measurement is taken after a CardioMEMS measurement | Diagnostic test | Vivio comparison to CardioMEMS |
Primary outcome
Comparing Vivio measurements to CardioMEMS measurements over time
Time frame: From enrollment to the end of participation at 30-90 days
To assess the longitudinal agreement between non-invasive hemodynamic signals collected using the Vivio System and pulmonary artery pressure (PAP) measurements obtained via the CardioMEMS HF System.
4 secondary outcomes
Assessment of KCCQ-12 Scores
Time frame: From time of enrollment to 12 months after completion of participant Vivio use
KCCQ-12 and Ventric HF Score Comparison
Time frame: From time of enrollment to end of participation at 30-90 days
Assessment of Ventric HF Scores
Time frame: From time of enrollment to end of participation at 30-90 days
Vivio and CardioMEMS measurements related to SAEs and other HF related events
Time frame: From time of enrollment to 2 years after completion of participant Vivio use
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivio measurement in people with Heart Failure, run by Ventric Health, LLC at 4 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 6 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
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?
Comparing Vivio measurements to CardioMEMS measurements over time (time frame: From enrollment to the end of participation at 30-90 days). 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 28 Jul 2026.