ASSURE WCD Clinical Evaluation - Detection and Safety Study

Cardiac Arrest, Sudden Clinical Trial

— ACE-DETECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887052
• Other study ID #: 3324582_B
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: June 18, 2019

Study information

• Verified date: March 2024
• Source: Kestra Medical Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD). A total of 130 adult subjects at risk for sudden cardiac arrest but otherwise protected by an Implantable Cardioverter Defibrillator (ICD) will be enrolled at 10 clinical sites in the United States. Subjects will wear the device for approximately 30 days during normal daily activities including sleep. The WCD shock alarms and shock functionality will be disabled. Shock Alarm Event Markers are recorded by the WCD and will be used for analysis of the primary outcome measure. All episodes recorded by the ASSURE WCD and/or the subject's ICD will be reviewed by independent clinical experts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 18, 2019
• Est. primary completion date: June 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males or females, age = 18 years

2. Patients with an active Implantable Cardioverter Defibrillator (ICD)

3. Left Ventricular Ejection Fraction (LVEF) = 40%, measured within the past year (12 months) by echocardiography, nuclear imaging (including MRI), or left ventricular angiography

4. Able and willing to provide written informed consent before undergoing any study-related procedures

Exclusion Criteria:

1. 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

2. Any known skin allergy or sensitivity to the study garment materials that will be next to the skin

3. Any breached or compromised skin on the upper body that would be exacerbated by wearing the study garment

4. Work with or are frequently around equipment that produces high electromagnetic fields, for example magnetic resonance imaging devices, power supply facilities, or welding equipment

5. 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

6. Any planned air travel during the participation period

7. Pregnancy

8. Use of mechanical circulatory support, including but not limited to Left Ventricular Assist Device (LVAD) or Total Artificial Heart

9. Implanted Cardiac Resynchronization Therapy Defibrillator (CRT-D)

10. Simultaneous plan/prescription for Holter monitor, mobile cardiac outpatient telemetry (MCOT), Event Recorder, or in-hospital telemetry

11. 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.

12. Under bust chest circumference greater than 52 inches or less than 28 inches

13. Current hospital inpatient

Related Conditions & MeSH terms

• Cardiac Arrest, Sudden
• Death, Sudden, Cardiac

Intervention

Device:
• ASSURE™ Wearable Cardioverter Defibrillator (WCD)
WCD with shock alarms and shock functionality disabled

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Kestra Medical Technologies, Inc.	Regulatory and Clinical Research Institute Inc

Country where clinical trial is conducted

United States, 

References & 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 fa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WCD False Positive Alarm Rate	False Shock Alarms per patient day	30 days
Secondary	WCD True Positive Detections	WCD recorded episodes annotated as VT or VF	30 days
Secondary	WCD Missed Events	WCD False Negative Detections	30 days