Status:
WITHDRAWN
Study of ADI CardioPulmonary Management (CPM) System
Lead Sponsor:
Analog Device, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 tha...
Detailed Description
Patients that participate in this study will be using a wearable device for 6 months. At their initial visit (visit 1), patients will undergo a brief physical exam, have their medical history and medi...
Eligibility Criteria
Inclusion
- Heart failure (HF) patients regardless of ejection fraction, HFpEF (heart failure preserved ejection fraction) or HFrEF (heart failure reserved ejection fraction) with one or more of the following:
- 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
- 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
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06024369
Start Date
March 1 2024
End Date
March 1 2024
Last Update
May 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tufts Medical Center
Boston, Massachusetts, United States, 02111