Heart Sounds Registry (HEARIT-Reg)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03203629|
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : April 23, 2021
|Condition or disease||Intervention/treatment|
|Heart Failure; With Decompensation||Device: Wearable Cardioverter Defibrillator (WCD)|
To conduct a prospective, observational study to evaluate the non-interventional feasibility of using heart sounds measurements recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD) for monitoring clinical evidence of heart failure decompensation.
Participants will be adult (age ≥ 18 years) heart failure patients with an ejection fraction (EF) ≤ 35% and eligible to wear the WCD for at least 3 months.
An FDA-approved WCD will be prescribed for at least 3 months of use after hospital discharge.
This is a multi-center, prospective, observational study.
The study will enroll a total of 300 subjects, anticipating that at least 250 subjects will complete the study. A maximum of 50 sites will enroll patients into the study.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||705 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Heart Sounds Registry In Patients Using The Wearable Cardioverter Defibrillator (HEARIT-Registry) Study Protocol|
|Actual Study Start Date :||June 5, 2017|
|Actual Primary Completion Date :||January 30, 2020|
|Actual Study Completion Date :||March 16, 2021|
- Device: Wearable Cardioverter Defibrillator (WCD)
Observe and compare the heart sound measurements recorded by the WCDOther Names:
- Observe the changes in the heart sounds measurement [ Time Frame: 3 months ]Observe the changes in the heart sounds measurement (recorded by the WCD) with clinical evidence of heart failure decompensation during the three month WCD treatment period.
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): NCT03203629
|Study Director:||Steven J. Szymkiewicz, MD||Zoll Medical Corporation|