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

NCT05980585 | Active Not Recruiting FDA Device

• 1 other identifier: OBS-BAPTISTJAX
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Interoperability of CPM system

  patient satisfaction with system obtained through survey questions; ease of use, impact and satisfaction; scale of 1-7 used with 1 being negative and 7 being positive, impact on daily life obtained though Minnesota Living with Heart Failure questionnaire

  60 days

Secondary Outcomes (1)

• Correlation of device data and clinical outcomes

  90 days

Study Arms (1)

Study Group

EXPERIMENTAL

The Study group will use the CPM device once daily (in the morning) for 60 days.

Device: CPM Device

Interventions

CPM Device DEVICE

Daily use of the CPM wearable device

Study Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• NYHA Class III-IV HF
• NYHA Class II HF patients with elevated BNP levels (BNP\>100 pg per mL) NYHA Class II HF patients with elevated NT-proBNP levels (NT-proBNP\>400 pg per mL)
• HF Patients with at least one Worsening HF event (in /out-patient) in past 12 months
• HF patients with Acute Renal Failure or Chronic Kidney Disease
• HF patients with Chronic Obstructive Pulmonary Disease (COPD)
• HF patients currently on 40 mg or more of Furosemide /

You may not qualify if:

• Under age 60
• End Stage Renal Disease
• Patients with severe COPD (GOLD stage III or IV)
• Limited mobility preventing application of device
• Cognitive impairments that would limit the application and proper use of the device
• Skin allergies or skin sensitivities to silicone-based adhesives
• Pregnancy
• Skin breakdown on the left chest or breast area
• Not willing to shave chest hair if needed to apply device
• No cellular coverage (Patient's Home)

Sponsors & Collaborators

• Analog Device, Inc.: lead

Study Sites (1)

Baptist Health

Jacksonville Beach, Florida, 32250, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participant, the investigator, and the outcomes assessor will all be masked to the device data during the trial.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study looks at a single group of patients that uses the CPM Device

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 8, 2023
• Study Start: April 20, 2022
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)