NCT03887052: ACE-DETECT

ASSURE WCD Clinical Evaluation - Detection and Safety Study

Completed NA Results posted Last updated 12 March 2024

What this trial tests

NA trial testing ASSURE™ Wearable Cardioverter Defibrillator (WCD) in Cardiac Arrest, Sudden in 130 participants. Completed in 18 June 2019.

Timeline

20 March 2019

Primary endpoint
18 June 2019

18 June 2019

Quick facts

Lead sponsor	Kestra Medical Technologies, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	130
Start date	20 March 2019
Primary completion	18 June 2019
Estimated completion	18 June 2019
Sites	10 locations across United States

Drugs / interventions tested

• ASSURE™ Wearable Cardioverter Defibrillator (WCD)

Conditions studied

• Cardiac Arrest, Sudden — all drugs for Cardiac Arrest, Sudden →

Sponsor

Kestra Medical Technologies, Inc.

Who can join

18 and older, any sex, with Cardiac Arrest, Sudden. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

WCD False Positive Alarm Rate Primary · 30 days

False Shock Alarms per patient day

Group	Value	95% CI
Study Arm	0.00075	0.00015 – 0.00361

WCD True Positive Detections Secondary · 30 days

WCD recorded episodes annotated as VT or VF

Group	Value	95% CI
Study Arm	4

WCD Missed Events Secondary · 30 days

WCD False Negative Detections

Group	Value	95% CI
Study Arm	0

Adverse events — posted to ClinicalTrials.gov

Time frame: During the period each patient wore the WCD, median 31.0 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Study Arm

Serious: 0/129 (0%)

Deaths: 0/129

Other adverse events (1 terms — click to expand)

Reaction	System	Study Arm
Skin Irritation	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03887052 adverse events section.

Sponsor's own 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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.