LifeVest Wearable Cardioverter Defibrillator WEARIT-III Registry

STUDY PROCEDURE

U.S. patients prescribed a commercially available WCD (ZOLL LifeVest) will be approached by a
letter from the sponsor which summarized the study purpose and procedure. Once a patient
signs a consent form to participate the study, he or she will receive three questionnaire
from University of Rochester, the coordination and data center for the WEARIT registry, at
the time enrollment, at 3 month and 12 month follow-up, respectively. At 3 and 12-month
follow-up, the physician of the patient will be contacted to provide information on
arrhythmias, and interim events (ICD, CRT or LVAD implantation, heart failure episode,
death), and to send us related hospital reports and echocardiogram reports to assess the
improvement in left ventricular function.

STUDY DESIGN

WEARIT-III is a prospective observational patient registry. Optimal pharmacologic and/or
implanted device therapy is anticipated, and the Registry physicians will not be involved in
any medical care of the subjects, only collecting information on the standard care of these
patients. In WEARIT-III we will also retrieve hospital records/echocardiogram reports of the
subjects during follow-up using an authorization form signed by the study subjects and
contact their physician to collect information on improvement of the left ventricular
function whenever it is available.

DATA MANAGEMENT, DATA STORAGE

Once consented, device recordings and prescribing information will be obtained from the
device provider. Data from the subject-completed questionnaire will also be obtained. Data
will be entered into our web-based, password-protected clinical data-management system. That
data will then be doubled-checked for accuracy by personnel working on the Registry. All
study documents will be kept in a locked file room. All computers are password-protected and
kept in a locked area.

DATA ANALYSIS

Routine patient clinical data as well as WCD data and clinical outcome during 1 year of
follow-up will be recorded on all study patients and entered into a study-specific data-
management system using our existing data management systems in the Heart Research Follow-up
Program.

All analyses will be performed based on the primary and secondary objectives. Patient's
clinical characteristics will be recorded and presented by descriptive statistics. Change in
the clinical course will be recorded by descriptive statistics and compared to pre- WCD and
post-WCD. Time-to-event analysis will be performed to assess the time until medication
optimization. Clinical event will be presented as person-time rate and will be compared to
previous WCD studies. Adverse events will be evaluated by raw counts and percentages.
Compliance will be analyzed by mean and median of length of use and daily wear time.

Inclusion Criteria:

1. Subjects of 18 years old or older;

2. Subjects who are recently diagnosed with heart failure of ischemic etiology (either
revascularized or cannot be revascularized);

3. NYHA functional class II, III, or IVa (ambulatory);

4. Left ventricular ejection fraction ≤ 35%;

5. Subject wearing a prescribed ZOLL LifeVest WCD;

6. Subject agrees to enter the Registry after appropriate informed consent.

Exclusion Criteria:

1. Subjects who are unable or unwilling to cooperate with the study protocol;

2. Subjects who are not willing to participate;

3. Subjects who have acute ST-segment elevation myocardial infarction (STEMI) within 30
days before prescribed with WCD;

4. Subjects with cardiomyopathy from mixed etiology;

5. Subjects with active or previously explanted cardiac devices such as ICD, CRT or LVAD
except for pacemaker;

6. Subjects with a life expectancy of less than a year, including end-stage heart
failure, cancer and end-stage renal disease.