ASSURE WCD Clinical Evaluation - Detection and Safety Study (ACE-DETECT)

Status: Completed
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
Alaska
Alaska Cardiovascular Research Foundation
Anchorage
Louisiana
Heart Clinic of Hammond, LA
Hammond
Maryland
Washington Adventist Hospital
Takoma Park
Michigan
University of Michigan
Ann Arbor
Minnesota
Mayo Clinic
Rochester
Missouri
Washington University St Louis
Saint Louis
New Jersey
Cooper University Health Care
Camden
Ohio
Toledo ProMedica Hospital
Toledo
Washington
University of Washington Medical Center
Seattle
Institute for Research and Innovation MultiCare Health System
Tacoma
Time Frame
Start Date: March 20, 2019
Completion Date: June 18, 2019
Participants
Target number of participants: 130
Treatments
Experimental: Study Arm
Adult cardiac patients at risk for sudden cardiac arrest otherwise protected with an Implantable Cardioverter Defibrillator (ICD)
Related Therapeutic Areas
Sponsors
Collaborators: Regulatory and Clinical Research Institute Inc
Leads: Kestra Medical Technologies, Inc.

This content was sourced from clinicaltrials.gov

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