LifeVest Wearable Cardioverter Defibrillator WEARIT-III Registry

NCT02700880 | Completed FDA Device

• 1 other identifier: WEARIT-III
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Heart Failure

Keywords

wearable cardioverter defibrillator; ischemic cardiomyopathy; new onset heart failure; sudden cardiac death

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• All-cause mortality

  1 year

• Number of inappropriate shocks

  1 year

• WCD shock conversion success rate

  1 year

• NYHA functional class

  At enrollment, 3-month and 1-year follow-up

Study Arms (1)

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

Interventions

LifeVest DEVICE

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.

Also known as: Wearable Cardioverter Defibrillator WCD

Heart failure patients with LifeVest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects of 18 years old or older;
• Subjects who are recently diagnosed with heart failure of ischemic etiology (either revascularized or cannot be revascularized);
• NYHA functional class II, III, or IVa (ambulatory);
• Left ventricular ejection fraction ≤ 35%;
• Subject wearing a prescribed ZOLL LifeVest WCD;
• Subject agrees to enter the Registry after appropriate informed consent.

You may not qualify if:

• Subjects who are unable or unwilling to cooperate with the study protocol;
• Subjects who are not willing to participate;
• Subjects who have acute ST-segment elevation myocardial infarction (STEMI) within 30 days before prescribed with WCD;
• Subjects with cardiomyopathy from mixed etiology;
• Subjects with active or previously explanted cardiac devices such as ICD, CRT or LVAD except for pacemaker;
• Subjects with a life expectancy of less than a year, including end-stage heart failure, cancer and end-stage renal disease.

Sponsors & Collaborators

• Zoll Medical Corporation: lead
• University of Rochester: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Valentina Kutyifa, MD,PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 7, 2016
• Study Start: June 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)