Clinical Data Collection Study Using CPM System

NCT06007079 | Recruiting FDA Device

• 1 other identifier: ADI-NYP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the deployment of the ADI CPM System in a home setting and determine the interoperability of the CPM System within existing care pathways for HF patients. Clinicians will be blinded to CPM generated data and acquired physiologic data will not be used in clinical decision-making. After conclusion of this phase, a retrospective review of CPM System-acquired data will be compared with changes in treatment and HF events. This retrospective review will inform the subsequent design of the interventional study that is planned. Study participation for each patient will last for six months inclusive of 5 months of daily CPM monitoring followed by 30 days of observation for HF-related events. The additional 30 days of medical record observation is intended to capture any events that might correspond to predictions made during the final weeks of CPM monitoring.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• Record number of heart failure events

  A HF hospitalization is defined as any unplanned visit to a hospital, Emergency Department or Observation unit with a length of stay of at least 24 hours AND treatment with intravenous diuretics. Worsening heart failure is defined as having at least one sign or symptom of congestion including but not limited to: worsening dyspnea, orthopnea, PND, JVD, S3 gallop, pulmonary crackles, ascites or edema. Urgent treatment is defined as any use of intravenous diuretic therapy or an increased diuretic dosage (at least 2x baseline dose) and/or additional class of diuretics.

  5 months

• Sensitivity

  Measuring the sensitivity of each parameter with respect to the ability to predict a CHF event. Sensitivity is defined as TP/(TP+FN) = True Positive/(True Positive+False Negative)

  6 months

• Specificity

  Measuring the specificity of each parameter with respect to the ability to predict a CHF event. Specificity is defined as TN/(TN+FP) = True Negative/(True Negative+False Positive)

  6 months

Secondary Outcomes (2)

• Patient compliance

  5 months

• Data quality

  5 months

Study Arms (1)

Device Use

EXPERIMENTAL

Patients will be given the CPM device to take home and use once daily

Device: CPM Device

Interventions

CPM Device DEVICE

Wearable monitor

Device Use

Eligibility Criteria

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

You may qualify if:

• NYHA Class III-IV
• NYHA Class II HF with one or more of the following:
• Chronic Kidney Disease (eGFR\<60)
• 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 for patients not in AF or \> 600 pg/m 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)
• Chronic Kidney Disease (eGFR \< 20)
• 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
• Patients on chronic inotropic therapy
• 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)

Sponsors & Collaborators

• Analog Device, Inc.: lead
• Columbia University: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Emily Wycallis

CONTACT

9784351644; emily.wycallis@analog.com

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 18, 2023
• First Posted: August 23, 2023
• Study Start: December 6, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)