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

NCT05978518 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-23

No results posted yet for this study

Summary

The primary purpose for this study is to support the hypothesis (pilot data) that the use of the 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 CPM system \& have their data reviewed by a physician against those who are using the CPM system and not having their data reviewed.

Conditions

Interventions

DEVICE

CPM Device + Monitoring

Daily device use \& data monitoring leading to symptomology assessment and notification to provider.

DRUG

CPM Device

Daily device use

Sponsors & Collaborators

  • Analog Device, Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-13
Primary Completion
2024-06-13
Completion
2025-12-20
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 NCT05978518 on ClinicalTrials.gov