LifeVest Wearable Cardioverter Defibrillator WEARIT-III Registry
Completed
Conditions studied: Ischemic Heart Failure
In brief
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.
Key facts
- Study ID
- NCT02700880
- Run by
- Zoll Medical Corporation
- People needed
- 250
- Starts
- 2014-06-01
- Expected to finish
- 2019-02-01
- Last updated by the study team
- 2019-03-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- University of Rochester Medical Center — Rochester, New York, United States
Full record on ClinicalTrials.gov
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