Heart Sounds Registry (HEARIT-Reg)
|Heart Failure; With Decompensation||Device: Wearable Cardioverter Defibrillator (WCD)|
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||3 Months|
|Official Title:||Heart Sounds Registry In Patients Using The Wearable Cardioverter Defibrillator (HEARIT-Registry) Study Protocol|
- 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.
|Actual Study Start Date:||June 5, 2017|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03203629
|Contact: Mike A Osz, B.Sc.||email@example.com|
|United States, South Carolina|
|Florence, South Carolina, United States, 29506|
|Study Director:||Mike A Osz, B.Sc.||Zoll Medical Corporation|