Heart Sounds Registry



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/6/2019
Start Date:June 5, 2017
End Date:June 2020
Contact:Mike A. Osz, B.Sc. (Hons)
Email:mosz@zoll.com
Phone:412-968-3472

Use our guide to learn which trials are right for you!

Heart Sounds Registry In Patients Using The Wearable Cardioverter Defibrillator (HEARIT-Registry) Study Protocol

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.

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.

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.
We found this trial at
18
sites
1403 East Greenville Street
Anderson, South Carolina 29625
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Anderson, SC
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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Fort Lauderdale, FL
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Atlantis, Florida 33462
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Atlantis, FL
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43230 Garfield Road
Clinton Township, Michigan 48038
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Clinton Township, MI
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555 East Cheves Street
Florence, South Carolina 29506
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Florence, SC
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1 Genesys Pkwy
Grand Blanc, Michigan 48439
(810) 606-5000
Genesys Regional Medical Center Genesys Health System, a member of Ascension Health, is a group...
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Grand Blanc, MI
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Graz,
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8111 South Emerson Avenue
Indianapolis, Indiana 46237
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Indianapolis, IN
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Lansing, Michigan 48912
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Lansing, MI
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401 Young Avenue
Moorestown, New Jersey 08057
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Moorestown, NJ
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886 Chestnut Ridge Road
Morgantown, West Virginia 26506
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Morgantown, WV
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10550 North Torrey Pines Road
National City, California 91950
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National City, CA
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Richmond, Virginia 23225
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Richmond, VA
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Saginaw, Michigan 48601
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Saginaw, MI
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Saint Petersburg, Florida 33709
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Saint Petersburg, FL
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Saratoga Springs, New York 12866
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Saratoga Springs, NY
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Urbana, Illinois 61801
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Urbana, IL
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2309 East Evesham Road
Voorhees, New Jersey 08043
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Voorhees, NJ
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