ASSURE WCD Clinical Evaluation - Detection and Safety Study

Completed · Not applicable

Conditions studied: Cardiac Arrest, Sudden

In brief

A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD).

Key facts

Study ID

NCT03887052

Run by

Kestra Medical Technologies, Inc.

People needed

130

Starts

2019-03-20

Expected to finish

2019-06-18

Last updated by the study team

2024-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females, age ≥ 18 years
• Patients with an active Implantable Cardioverter Defibrillator (ICD)
• Left Ventricular Ejection Fraction (LVEF) ≤ 40%, measured within the past year (12 months) by echocardiography, nuclear imaging (including MRI), or left ventricular angiography
• Able and willing to provide written informed consent before undergoing any study-related procedures

You may not qualify if…

• Any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements, including cognitive and/or physical limitations that would prevent the subject from interacting with the device as intended
• Any known skin allergy or sensitivity to the study garment materials that will be next to the skin
• Any breached or compromised skin on the upper body that would be exacerbated by wearing the study garment
• Work with or are frequently around equipment that produces high electromagnetic fields, for example magnetic resonance imaging devices, power supply facilities, or welding equipment
• Any planned surgical or medical procedures during the participation period that would require the subject to remove the study device for more than 12 hours
• Any planned air travel during the participation period
• Pregnancy
• Use of mechanical circulatory support, including but not limited to Left Ventricular Assist Device (LVAD) or Total Artificial Heart
• Implanted Cardiac Resynchronization Therapy Defibrillator (CRT-D)
• Simultaneous plan/prescription for Holter monitor, mobile cardiac outpatient telemetry (MCOT), Event Recorder, or in-hospital telemetry
• Use of any electronic medical device that is worn on or near the body requires Sponsor approval, other than continuous positive airway pressure (CPAP), continuous blood glucose monitor, or pulse oximeter oxygen saturation (SpO2) monitor.
• Under bust chest circumference greater than 52 inches or less than 28 inches
• Current hospital inpatient

Where it is running

• Alaska Cardiovascular Research Foundation — Anchorage, Alaska, United States
• Heart Clinic of Hammond, LA — Hammond, Louisiana, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University St Louis — St Louis, Missouri, United States
• Cooper University Health Care — Camden, New Jersey, United States
• Toledo ProMedica Hospital — Toledo, Ohio, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Institute for Research and Innovation MultiCare Health System — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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