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
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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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1403 East Greenville Street
Anderson, South Carolina 29625
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Anderson, SC
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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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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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