Heart Failure Optimization Study



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:March 1, 2017
End Date:January 2020
Contact:Rachel Jackson
Email:rjackson@zoll.com
Phone:412-968-3333

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This study is designed as a multi-center prospective observational study of newly diagnosed
Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF)
recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is
achieved. Although the study doesn't start until day 90, all eligible, consenting patients
will be entered into a registry at the start of wearable cardioverter defibrillator (WCD)
use. The pre-study registry will allow us to collect early (90 day) outcomes and data in
those patients who are likely to be eligible for the study at day 90, or are eligible, but
refuse the study at day 90.

This study will be conducted at thirty to sixty sites, initially in US and Europe. It will be
used to observe the rate of recovery of ventricular function (EF>35%) between 90 and 180 days
in newly diagnosed HF patients who were prescribed the WCD ≤ 10 days post-discharge after
hospitalization for a primary reason of new onset HF (≤30 days since first HF
hospitalization), with ischemic or non-ischemic cardiomyopathy, and have already used a WCD
for 90 ± 14 days. For the first 90 days of WCD use, patients will be enrolled in a pre-study
registry. The FDA-approved WCD will be prescribed for up to 6 months of use after hospital
discharge, with the option for longer use under physician discretion. Approximately 870
subjects will enroll into the pre-study registry and 750 subjects into the study.

Inclusion Criteria:

Part 1

- Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after
hospitalization for a primary reason of new onset HF (≤30 days since first HF
hospitalization), with ischemic or nonischemic cardiomyopathy, and have used the WCD
for no more than 30 days.

- Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if
performed multiple times).

Part 2

- Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after
hospitalization for a primary reason of new onset HF (≤30 days since first HF
hospitalization), with ischemic or nonischemic cardiomyopathy, and have already used a
WCD for 90 ± 14 days.

- Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if
performed multiple times). Of note, EF at 90 ± 14 days post-hospitalization does not
need to be low to be included in the study.

Exclusion Criteria:

- Patients under 18 years old.

- Patients who have an active unipolar pacemaker.

- Patients with a physical or mental condition that could impair their ability to
properly interact with the device.

- Patients currently participating in another clinical study.

- Patients with any skin condition that would prevent wearing the device.

- Patients with an advanced directive prohibiting resuscitation.

- Patients who are indicated for cardiac resynchronization therapy or have a QRS
duration of ≥135 ms.

- Patients with recent myocardial infarction or coronary revascularization (since start
of WCD wear; i.e. 0-90 days of WCD wear).
We found this trial at
37
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Aurora, IL
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Barberton, Ohio 44203
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Barberton, OH
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Birmingham, Alabama 35294
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Birmingham, AL
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3435 Bailey Avenue
Buffalo, New York 14215
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CHapel Hill, North Carolina 27599
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CHapel Hill, NC
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Dallas, TX
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1348 South 18th Street
Fernandina Beach, Florida 32034
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Fernandina Beach, FL
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30 Prospect Avenue
Hackensack, New Jersey 07601
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Hackensack, NJ
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17800 Kedzie Avenue
Hazel Crest, Illinois 60429
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Hazel Crest, IL
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Huntington, West Virginia 25702
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Jackson, Mississippi 39216
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Jackson, MS
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Jacksonville, Florida 32207
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Jacksonville Beach, Florida 32250
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Jacksonville Beach, FL
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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1029 West Meeting Street
Lancaster, South Carolina 29720
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Lancaster, SC
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Linz,
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4820 West Taft Road
Liverpool, New York 13088
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1265 Union Avenue
Memphis, Tennessee 38104
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1300 Wesley Drive
Memphis, Tennessee 38116
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Munster, IN
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479 Oxford
New Braunfels, Texas 78130
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80 Vermont Avenue
Oak Ridge, Tennessee 37830
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Ocala, FL
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Orlando, Florida 32825
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815 Main Street
Peoria, Illinois 61602
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Pomona, New Jersey 08240
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Saint Louis, Missouri 63136
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Saint Petersburg, Florida 33713
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Sayre, Pennsylvania 18840
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Sioux Falls, South Dakota 57104
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South Bend, Indiana 46601
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Voorhees, New Jersey 08043
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Waco, Texas 76712
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Waco, TX
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West Hills, CA
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