Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02700880
Study type Observational [Patient Registry]
Source Zoll Medical Corporation
Contact
Status Active, not recruiting
Phase N/A
Start date June 2014
Completion date February 2019

See also
  Status Clinical Trial Phase
Terminated NCT02240940 - PARACHUTE China Approval Trial N/A
Completed NCT00846001 - Resynchronization Surgery Combined Unified Efficacy Phase 3
Active, not recruiting NCT01961726 - Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure Phase 1/Phase 2
Terminated NCT00102128 - Study to Examine the Safety and Effectiveness of Implanted Skeletal Muscle Cells (Cells Removed From the Thigh Muscle) Into Scarred Areas of Heart Muscle After Heart Attack. Phase 2
Not yet recruiting NCT03491969 - Clinical Study of Lipoic Acid on Ischemic Heart Failure Phase 4
Recruiting NCT01555320 - Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure N/A
Recruiting NCT02875639 - A Clinical Research of Qi Deficiency and Blood Stasis Syndrome (Different Disease With Syndrome) Phase 2
Active, not recruiting NCT01643590 - Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure. Phase 2
Active, not recruiting NCT02115568 - Registry to Assess Safety for Subjects That Have Completed a Juventas Sponsored HF Protocol Under IND # 14203 N/A
Recruiting NCT03206593 - Serum Lipids and Glucose Levels in Relation to CVD Outcomes in Patients With Ischemic Heart Failure N/A
Enrolling by invitation NCT01709279 - Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure N/A