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
Saratoga Springs, New York 12866
523
mi
from 43215
Saratoga Springs, NY
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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...
970
mi
from 43215
Fort Lauderdale, FL
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1403 East Greenville Street
Anderson, South Carolina 29625
376
mi
from 43215
Anderson, SC
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Atlantis, Florida 33462
940
mi
from 43215
Atlantis, FL
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43230 Garfield Road
Clinton Township, Michigan 48038
183
mi
from 43215
Clinton Township, MI
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555 East Cheves Street
Florence, South Carolina 29506
437
mi
from 43215
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...
206
mi
from 43215
Grand Blanc, MI
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4617
mi
from 43215
Graz,
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8111 South Emerson Avenue
Indianapolis, Indiana 46237
163
mi
from 43215
Indianapolis, IN
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Lansing, Michigan 48912
207
mi
from 43215
Lansing, MI
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401 Young Avenue
Moorestown, New Jersey 08057
429
mi
from 43215
Moorestown, NJ
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886 Chestnut Ridge Road
Morgantown, West Virginia 26506
164
mi
from 43215
Morgantown, WV
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10550 North Torrey Pines Road
National City, California 91950
1950
mi
from 43215
National City, CA
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Richmond, Virginia 23225
?
mi
from 43215
Richmond, VA
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Saginaw, Michigan 48601
242
mi
from 43215
Saginaw, MI
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Saint Petersburg, Florida 33709
838
mi
from 43215
Saint Petersburg, FL
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Urbana, Illinois 61801
274
mi
from 43215
Urbana, IL
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2309 East Evesham Road
Voorhees, New Jersey 08043
427
mi
from 43215
Voorhees, NJ
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