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

Launched by ANALOG DEVICE, INC. · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new system called the CardioPulmonary Management (CPM) System to see if it can help patients with chronic heart failure. The main goals are to find out if using this system can lower the number of heart failure-related health issues and reduce healthcare costs. Researchers will compare the health outcomes and costs for patients using the CPM system with those who are not using it, to see if there are any benefits in terms of quality of care and patient satisfaction.

To be eligible for this study, participants need to be adults aged 65 and older who have heart failure, which can be classified into different types based on their symptoms and heart function. They should have had recent heart failure-related hospital visits or certain health markers that show their condition is serious. However, people who are under 18, have severe lung problems, or other specific health issues may not qualify. If you join the study, you'll be monitored closely, and the research team will guide you on how to use the CPM system. This is a great opportunity to contribute to understanding how to improve care for others with heart failure while potentially benefiting from the new technology yourself.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Heart failure patients regardless of ejection fraction (HFpEF or HFrEF) with one or more of the following:
• • 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\* for patients not in 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)
• Exclusion Criteria:
• • 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 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