Study of ADI CardioPulmonary Management (CPM) System
Reason given: Change in staff / resources, sponsor decided not to pursue study.
Key facts
- Where
- Boston, United StatesSee the site
Where in United States
- Tufts Medical CenterBoston, United StatesNo longer taking part
Trial details
- Who runs it
- Analog Device, Inc.
- Trial code
- NCT06024369
- Record updated
- 16 May 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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).
Exclusion: Patients on chronic IV (intravenous) ionotropic therapy - (Milrinone, Dobutamine, and Dopamine); Skin allergies or skin sensitivities to silicone-based adhesives; Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator; 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; Pregnancy (method of assessment at the discretion of the PI); Not willing to shave chest hair if needed to apply device; No cellular coverage (Patient's Home)**; Skin breakdown on the left chest or breast area.