Heart Sounds Registry (HEARIT-Reg)
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ClinicalTrials.gov Identifier: NCT03203629 |
Recruitment Status :
Completed
First Posted : June 29, 2017
Last Update Posted : April 23, 2021
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Condition or disease | Intervention/treatment |
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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 |
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 |
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:
- LifeVest
- WCD
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients who are prescribed the WCD ≤ 10 days post-discharge after hospitalization with Heart Failure (HF), with and ischemic or non-ischemic cardiomyopathy.
- Patients who have an ejection fraction (EF) ≤ 35% at the time of WCD prescription.
- Patients are anticipated to wear the WCD for at least 3 months.
- The subject must be 18 years of age or older on the day of screening.
Exclusion Criteria:
- Patients with pacemakers, an implanted cardioverter defibrillator (ICD), or a cardiac resynchronization therapy device.
- Patients waiting for heart transplant.
- Patients with known evidence of atrial fibrillation on their most recent ECG recording.
- Patients currently hospitalized for acute myocardial infarction.
- Patients with a planned revascularization within 30 days of screening.
- Patients who are self-reporting to be pregnant.
- Patients participating in another clinical study.
- Patients not expected to live longer than 1 year.
- For patients in the United States, those who are unable or unwilling to provide written informed consent in English.
- For patients in Europe, those who are unable or unwilling to provide written informed consent in their country specific language or English.

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 |
Responsible Party: | Zoll Medical Corporation |
ClinicalTrials.gov Identifier: | NCT03203629 |
Other Study ID Numbers: |
90D0164 |
First Posted: | June 29, 2017 Key Record Dates |
Last Update Posted: | April 23, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Heart Failure Heart Diseases Cardiovascular Diseases |