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RECRUITING
NCT05650541
NA

Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure

Sponsor: Analog Device, Inc.

View on ClinicalTrials.gov

Summary

The primary purpose for this study is to support the hypothesis (pilot data) that the use of the Sensinel CPM system reduces the rate of HF-related events and the related healthcare cost. The study will also measure the impact on quality of care and patient satisfaction. In order to support the primary objective, the study will compare the outcomes and costs for patients using the Sensinel CPM system against those who are not. This can either be done using institutions' averages, if available, or through a control group.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2023-09-22

Completion Date

2026-06-01

Last Updated

2026-01-30

Healthy Volunteers

No

Conditions

Interventions

DEVICE

CardioPumlonary Management System

The CPM Device measures and trends a variety of physiologic parameters including thoracic impedance, respiration rate, tidal volume, ECG, heart rate, and diastolic heart sounds, all in an unobtrusive patch form factor.

Locations (7)

Desert Oasis Healthcare

Palm Springs, California, United States

Baptist Health South Florida

Miami, Florida, United States

Orlando Health

Orlando, Florida, United States

Baystate Medical Center

Springfield, Massachusetts, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Cone Health

Greensboro, North Carolina, United States

Prisma Health

Greenville, South Carolina, United States