CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test systemdevice
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/NCT04132466
NCT04132466N/ACompleted
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ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)

Kestra Medical Technologies, Inc.·interventional·Posted Oct 18, 2019·Updated Apr 5, 2024

In Brief

A clinical study evaluating Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system for Death, Sudden, Cardiac. Completed, enrolled 13 participants across 4 sites.

Detailed Summary

A multicenter single arm open label evaluation of the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform in adult cardiac patients

Study Details

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

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 18, 2019
Enrollment StartNov 25, 2019
Primary CompletionMar 19, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.7 years ago

Interventions

Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test systemdevice

defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator