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Assessment of Heart Failure (HF) At-Home Management Solution ADI Cardio Pulmonary Monitoring System (CPM)

NCT05980585 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-23

No results posted yet for this study

Summary

This study is meant primarily to assess the deployment of the ADI CPM System in a clinical setting and determine interoperability of the CPM System within existing care pathways for patients with CHF. In this initial study the CPM System will not be used to determine or support clinical decision making however post deployment the clinical study team will review patient HF events and changes in treatment during the course of the deployment and compare to the data generated by the CPM System during the study to determine the accuracy of the patient generated data as a basis for designing a more comprehensive "interventional study" to determine clinical and financial efficacy of the CPM System.

Conditions

Interventions

DEVICE

CPM Device

Daily use of the CPM wearable device

Sponsors & Collaborators

  • Analog Device, Inc.

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2025-04-01
Completion
2025-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05980585 on ClinicalTrials.gov