LifeVest Wearable Cardioverter Defibrillator WEARIT-III Registry (WEARIT-III)

Prospective Registry of Patients With Ischemic Heart Failure Using the LifeVest Wearable Cardioverter Defibrillator (WEARIT-III)

The WEARIT-III registry enrolls subjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Defibrillator. The primary objective of the WEARIT-III Registry is to prospectively document the clinical course of high-risk cardiac patients with heart failure and ischemic cardiomyopathy prescribed with Wearable Cardioverter Defibrillator (WCD), such as left ventricular function recovery, arrhythmia, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), Left Ventricular Assist Device (LVAD), heart transplantation, and to assess the benefit of WCD in heart failure patients with ischemic cardiomyopathy.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Failure
• Intervention / Treatment: Device: LifeVest

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

In WEARIT-III, subjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Cardioverter Defibrillator (WCD) and agree to enter the Registry after appropriate informed consent will be enrolled.

It is anticipated that approximately 1000 patients with ischemic cardiomyopathy and heart failure (≥18 years of age) will be enrolled in 2 years. No individuals shall be excluded from participation in the Registry based on race, ethnicity or gender.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Heart failure patients with LifeVest; Subjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Defibrillator	Device: LifeVest; LifeVest monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy.; Other Names: Wearable Cardioverter Defibrillator WCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of clinical events in heart failure patients with ischemic cardiomyopathy prescribed wearable cardioverter defibrillator (WCD)	The primary objective of the WEARIT-III Registry is to prospectively document the clinical course of high-risk cardiac patients with heart failure and ischemic cardiomyopathy prescribed with WCD, such as left ventricular function recovery, arrhythmia, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT), left ventricular assist device (LVAD), heart transplantation, and to assess the benefit of WCD in heart failure patients with ischemic cardiomyopathy.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Evaluate the number of deaths and the cause of death in patients with ischemic cardiomyopathy and heart failure prescribed with WCD.	1 year
Number of inappropriate shocks	Evaluate the safety of WCD in patients with ischemic cardiomyopathy and heart failure measured by the frequency of inappropriate WCD shocks	1 year
WCD shock conversion success rate	Evaluate WCD shock efficacy measured by shock conversion success rate among WCD appropriate shocks	1 year
NYHA functional class	Evaluate the NYHA functional class of heart failure patients with ischemic cardiomyopathy at enrollment, 3-month and 1-year after the initial prescription of the WCD in WEARIT-III	At enrollment, 3-month and 1-year follow-up

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Collaborators: University of Rochester
• Investigators: Principal Investigator: Valentina Kutyifa, MD,PhD, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 7, 2016

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: sudden cardiac death; ischemic cardiomyopathy; wearable cardioverter defibrillator; new onset heart failure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Heart Failure; Ischemia
• Other Study ID Numbers: WEARIT-III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes