ASSURE WCD Clinical Evaluation - Detection and Safety Study

NCT03887052 | Completed Results FDA Device

• 1 other identifier: 3324582_B
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Cardiac Arrest, Sudden

Outcome Measures

Primary Outcomes (1)

• WCD False Positive Alarm Rate

  False Shock Alarms per patient day

  30 days

Secondary Outcomes (2)

• WCD True Positive Detections

  30 days

• WCD Missed Events

  30 days

Study Arms (1)

Study Arm

EXPERIMENTAL

Adult cardiac patients at risk for sudden cardiac arrest otherwise protected with an Implantable Cardioverter Defibrillator (ICD)

Device: ASSURE™ Wearable Cardioverter Defibrillator (WCD)

Interventions

ASSURE™ Wearable Cardioverter Defibrillator (WCD) DEVICE

WCD with shock alarms and shock functionality disabled

Study Arm

Eligibility Criteria

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

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

Sponsors & Collaborators

• Kestra Medical Technologies, Inc.: lead
• Regulatory and Clinical Research Institute Inc: collaborator

Study Sites (10)

Alaska Cardiovascular Research Foundation

Anchorage, Alaska, 99508, United States

Location

Heart Clinic of Hammond, LA

Hammond, Louisiana, 70403, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University St Louis

St Louis, Missouri, 63110, United States

Location

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location

Toledo ProMedica Hospital

Toledo, Ohio, 43615, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Institute for Research and Innovation MultiCare Health System

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• Poole JE, Gleva MJ, Birgersdotter-Green U, Branch KRH, Doshi RN, Salam T, Crawford TC, Willcox ME, Sridhar AM, Mikdadi G, Beinart SC, Cha YM, Russo AM, Rowbotham RK, Sullivan J, Gustavson LM, Kivilaid K. A wearable cardioverter defibrillator with a low false alarm rate. J Cardiovasc Electrophysiol. 2022 May;33(5):831-842. doi: 10.1111/jce.15417. Epub 2022 Feb 28.

  PMID: 35174572 RESULT

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

Limitations and Caveats

The primary purpose of this study was to assess the false positive shock alarm rate; however, our results may not translate to the results of a larger study with longer wear time. Because auditory/vibratory alarms and shocks were disabled in this study, reported wear compliance may not reflect clinical use when this functionality is enabled. Further prospective large studies will enable assessment of overall WCD performance and patient compliance.

Results Point of Contact

• Title: Laura Gustavson, VP Clinical Marketing
• Organization: Kestra Medical Technologies, Inc.

laura.gustavson@kestramedical.com

14255264759

Study Officials

• Jeanne E. Poole, MD

  University of Washington Medical Center, Seattle

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter single arm open label evaluation

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 22, 2019
• Study Start: March 20, 2019
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: March 12, 2024
• Results First Posted: October 26, 2023

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)