Heart Failure Monitoring With Eko Electronic Stethoscopes (CardioMEMS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05080504|
Recruitment Status : Not yet recruiting
First Posted : October 15, 2021
Last Update Posted : October 28, 2021
|Condition or disease||Intervention/treatment|
|Heart Failure||Device: Eko DUO|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Heart Failure Monitoring With Eko Electronic Stethoscopes (CardioMEMS)|
|Estimated Study Start Date :||November 1, 2021|
|Estimated Primary Completion Date :||May 1, 2022|
|Estimated Study Completion Date :||May 1, 2022|
Subjects with implanted CardioMEMS who are actively managed through Columbia University Medical Center will be enrolled.
Device: Eko DUO
Each subject will take an Eko DUO device home and take DUO recordings immediately before or after their prescribed CardioMEMS measurements.
The DUO recordings will be taken at 3 predefined chest locations: the right upper sternal border, left upper sternal border, and right anterolateral. Each DUO recording lasts about 15 seconds. The total time per recording session is expected to be 2-4 minutes, which allows for time between recordings and any potential repeat recordings. Study participation will last for 90 days.
- Correlation between AI/ML model output and the ground-truth of CardioMEMS PA pressure measurements. [ Time Frame: 6 months ]The primary objective of this proof of concept study is to demonstrate whether Eko data scientists can create an artificial intelligence machine learning (AI/ML) model of pulmonary artery (PA) pressures by analyzing sound and electrical (ECG) signals of heart activity captured by the non-invasive, FDA-cleared, Eko DUO electronic stethoscope.
- Composite of the incidence of poor-quality ECG or PCG data and tabulation of patient compliance with the data measurement schedule [ Time Frame: 6 months ]A secondary objective of the study is to assess the usability of the Eko DUO by patients at home
- Intra-subject reproducibility of measured variables [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05080504
|Contact: Ben Verschoore, BSfirstname.lastname@example.org|
|Principal Investigator:||Nir Uriel, MD||Columbia University|
|Principal Investigator:||Gabriel Sayer, MD||Columbia University|