Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    HEARIT
Previous Study | Return to List | Next Study

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
Sponsor:
Information provided by (Responsible Party):
Zoll Medical Corporation

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Show Show 33 study locations
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
Layout table for investigator information
Study Director: Steven J. Szymkiewicz, MD Zoll Medical Corporation
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
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

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases