CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 130 enrolled
Drug / intervention
ASSURE™ Wearable Cardioverter Defibrillator (WCD)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03887052
NCT03887052N/ACompleted
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ASSURE WCD Clinical Evaluation - Detection and Safety Study (ACE-DETECT)

Kestra Medical Technologies, Inc.·interventional·Posted Mar 22, 2019·Updated Mar 12, 2024

In Brief

A clinical study evaluating ASSURE™ Wearable Cardioverter Defibrillator (WCD) for Cardiac Arrest, Sudden. Completed, enrolled 130 participants across 10 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Arrest, Sudden
CountriesUnited States
CollaboratorsRegulatory and Clinical Research Institute Inc

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 22, 2019
Enrollment StartMar 20, 2019
Primary CompletionJun 18, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.3 years ago

Interventions

ASSURE™ Wearable Cardioverter Defibrillator (WCD)device

WCD with shock alarms and shock functionality disabled