Study of ADI CardioPulmonary Management (CPM) System

NCT06024369 | Withdrawn FDA Device

• 1 other identifier: TUFTS-PILOT-1.0
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is meant primarily collect CardioPulmonary Management (CPM) data from daily usage and compare it to the clinical course of a patient. For this study, the only aspect of the CPM solution that will be used will be the device itself and the mobile application to assign devices to patients. The patients will be assigned a device at visit one and take the device home. They will use the device once daily (when they first wake up) for 6 months. The patient will come in for visit 2 to return the device.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• Patient Satisfaction with Device

  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. Higher scores indicate more satisfaction with device.

  6 months

• Correlation of device data and clinical outcomes

  Retrospective review of data to determine correlation of patient specific device measurements (such as increase/decrease in specific device parameters) with heart failure events. Measurements include thoracic impedance, respiration rate (RR), heart rate (HR), relative tidal volume (rTV), RR variability, HR variability, RR/rTV, QRS width, QTc width, presence of atrial fibrillation, and diastolic heart sound strength

  7 months

• Patient Quality of Life

  Patient quality of live measured through the Minnesota Living with Heart Failure questionnaire. The questionnaire measures how heart failure impacts the patient's life scale is 0-5. 0 is does not apply, 1 is very little and 5 is very much. Higher scores indicate a worse quality of life.

  6 months

Secondary Outcomes (1)

• Compliance rates

  6 months

Study Arms (1)

Using wearable CPM Device daily

EXPERIMENTAL

The patients will be using the wearable device once daily at home for 6 months.

Device: CPM Device

Interventions

CPM Device DEVICE

Wearable monitor used for 5 minutes per day.

Using wearable CPM Device daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New York Heart Association (NYHA) Class III HF
• NYHA Class IV HF OR
• NYHA Class II HF with one/. or more of the following:
• Chronic Kidney Disease (eGFR\<60 within the past 6 months)
• HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP \> 200 pg/ml\* (N-terminal pro b-type natriuretic peptide) for patients not in atrial fibrillation (AF) or \> 600 pg/ml\* for patients in AF on screening ECG+
• NT-proBNP \> 300 pg/ml\* for patients not in AF or \> 900 pg/ml\* for patients in AF on the screening visit ECG+
• Chronic obstructive pulmonary disease (COPD)

You may not qualify if:

• Under 18 years of age
• Patients with severe COPD (GOLD stage III or IV)
• Limited mobility preventing application of device or no caregiver to assist
• Cognitive impairments that would limit the application and proper use of the device
• Skin allergies or skin sensitivities to silicone-based adhesives
• Pregnancy (method of assessment at the discretion of the PI)
• Not willing to shave chest hair if needed to apply device
• Patients on chronic IV (intravenous) ionotropic therapy - (Milrinone, Dobutamine, and Dopamine)
• Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator
• No cellular coverage (Patient's Home)\*\*
• Skin breakdown on the left chest or breast area

Sponsors & Collaborators

• Analog Device, Inc.: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, 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
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 6, 2023
• Study Start: March 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)