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Heart Sounds Registry (HEARIT-Reg)

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ClinicalTrials.gov Identifier: NCT03203629
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Zoll Medical Corporation

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Heart Failure; With Decompensation Device: Wearable Cardioverter Defibrillator (WCD)

Detailed Description:

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Intervention Details:
  • Device: Wearable Cardioverter Defibrillator (WCD)
    Observe and compare the heart sound measurements recorded by the WCD
    Other Names:
    • LifeVest
    • WCD

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Mike A. Osz, B.Sc. (Hons) 412-968-3472 mosz@zoll.com
Contact: Leah Zeiler, MS +1-412-968-3518 lzeiler@zoll.com

  Show 33 Study Locations
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
Study Director: Steven J. Szymkiewicz, MD Zoll Medical Corporation
More Information
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Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT03203629     History of Changes
Other Study ID Numbers: 90D0164
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases