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Trial record 1 of 1 for:    HEARIT
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Heart Sounds Registry (HEARIT-Reg)

This study is currently recruiting participants.
Verified June 2017 by Zoll Medical Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT03203629
First Posted: June 29, 2017
Last Update Posted: June 29, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Zoll Medical Corporation
  Purpose
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 Intervention
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

Resource links provided by NLM:


Further study details as provided by Zoll Medical Corporation:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 300
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)
Intervention Details:
    Device: Wearable Cardioverter Defibrillator (WCD)
    Observe and compare the heart sound measurements recorded by the WCD
    Other Names:
    • LifeVest
    • 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.

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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. 412-968-3472 mosz@zoll.com

Locations
United States, South Carolina
McLeod Regional Recruiting
Florence, South Carolina, United States, 29506
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
Study Director: Mike A Osz, B.Sc. Zoll Medical Corporation
  More Information

Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT03203629     History of Changes
Other Study ID Numbers: 90D0164
First Submitted: June 14, 2017
First Posted: June 29, 2017
Last Update Posted: June 29, 2017
Last Verified: June 2017
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