Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
705 participants
OBSERVATIONAL
2017-06-05
2021-03-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Wearable Cardioverter Defibrillator (WCD)
Observe and compare the heart sound measurements recorded by the WCD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Zoll Medical Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Steven J. Szymkiewicz, MD
Role: STUDY_DIRECTOR
Zoll Medical Corporation
Locations
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MD Strategies Research Center
National City, California, United States
JFK Medical Center
Atlantis, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Northside Hospital / Heart Institute
St. Petersburg, Florida, United States
Carle Foundation Hospital
Urbana, Illinois, United States
FRANCISCAN HEALTH Indianapolis
Indianapolis, Indiana, United States
Cardiovascular Institute of Michigan
Clinton Township, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Michigan CardioVascular Institute
Saginaw, Michigan, United States
Virtua The Cardiology Group
Moorestown, New Jersey, United States
Virtua The Cardiology Group
Voorhees Township, New Jersey, United States
Saratoga Clinical Research
Saratoga Springs, New York, United States
MD First Research
Anderson, South Carolina, United States
McLeod Regional
Florence, South Carolina, United States
Chippenham Medical Center
Richmond, Virginia, United States
West Virginia University Research
Morgantown, West Virginia, United States
Medizinische Universität Graz
Graz, , Austria
Charité Berlin Benjamin Franklin
Berlin, , Germany
Herzzentrum Dresden
Dresden, , Germany
Uni Erlangen
Erlangen, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
Albertinenkrankenhaus HamburgKardiologie Albertinen-Krankenhaus
Hamburg, , Germany
Asklepios St. Georg Hamburg
Hamburg, , Germany
Sana Klinikum Hof,
Hof, , Germany
Krankenhaus und MVZ Maria-Hilf Stadtlohn GmbH
Stadtlohn, , Germany
University of Würzburg, Medizinische Klinik und Poliklinik I
Würzburg, , Germany
American Heart of Poland S.A.
Chrzanów, , Poland
Wissmed Gdanskie Centrum
Gdansk, , Poland
Klinika Elektrokardiologii Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Spzoz Msw
Rzeszów, , Poland
EMED Centrum Uslug Medycznych
Rzeszów, , Poland
Wojewodzki Szpital Zespolony
Torun, , Poland
Countries
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Other Identifiers
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90D0164
Identifier Type: -
Identifier Source: org_study_id
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