Status:
ACTIVE_NOT_RECRUITING
Assessment of Heart Failure (HF) At-Home Management Solution ADI Cardio Pulmonary Monitoring System (CPM)
Lead Sponsor:
Analog Device, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18-60 years
Phase:
NA
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....
Detailed Description
Patients will be recruited and begin the study as they are identified and consent to the study. Recruiting will end either by a designated date set at the initiation of the study or when 30 patients h...
Eligibility Criteria
Inclusion
- one or more of the following
- 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 /
Exclusion
- 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)
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05980585
Start Date
April 20 2022
End Date
June 1 2025
Last Update
February 23 2024
Active Locations (1)
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1
Baptist Health
Jacksonville Beach, Florida, United States, 32250