NCT07730268

Brief 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. 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
42mo left

Started Oct 2025

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

4 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Oct 2025Dec 2029

Study Start

First participant enrolled

October 20, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

3.2 years

First QC Date

July 14, 2026

Last Update Submit

July 23, 2026

Conditions

Heart Failure

Keywords

Pulmonary artery pressureHeart FailureVivioVentricNon-InvasiveDiagnostic

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of participation at 30-90 days

Secondary Outcomes (4)

  • Assessment of KCCQ-12 Scores

    From time of enrollment to 12 months after completion of participant Vivio use

  • KCCQ-12 and Ventric HF Score Comparison

    From time of enrollment to end of participation at 30-90 days

  • Assessment of Ventric HF Scores

    From time of enrollment to end of participation at 30-90 days

  • Vivio and CardioMEMS measurements related to SAEs and other HF related events

    From time of enrollment to 2 years after completion of participant Vivio use

Study Arms (1)

Vivio comparison to CardioMEMS

EXPERIMENTAL

Observational comparison of Vivio measurements to CardioMEMS measurements

Diagnostic Test: Vivio measurement

Interventions

Vivio measurementDIAGNOSTIC_TEST

The Vivio measurement is taken after a CardioMEMS measurement

Vivio comparison to CardioMEMS

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult subjects over the age of 21.
  • A CardioMEMS HF System implanted or scheduled to be implanted.
  • % 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.

You may not qualify if:

  • Open skin lesions at the site of Vivio application / examination.
  • Inability to obtain brachial artery blood pressure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

MemorialCare Long Beach Medical Center

Long Beach, California, 90806, United States

Location

USC Keck School of Medicine

Los Angeles, California, 90033, United States

Location

UC San Diego School of Medicine

San Diego, California, 92037, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

MeSH Terms

Conditions

Heart FailureDisease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 28, 2026

Study Start

October 20, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(4)