NCT04132466: ACE-CONVERT

ASSURE WCD Clinical Evaluation - Conversion Efficacy Study

Completed NA Results posted Last updated 5 April 2024

What this trial tests

NA trial testing Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system in Death, Sudden, Cardiac in 13 participants. Completed in 19 March 2020.

Timeline

25 November 2019

Primary endpoint
19 March 2020

19 March 2020

Quick facts

Lead sponsor	Kestra Medical Technologies, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	25 November 2019
Primary completion	19 March 2020
Estimated completion	19 March 2020
Sites	4 locations across United States

Drugs / interventions tested

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

Conditions studied

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

Sponsor

Kestra Medical Technologies, Inc.

Who can join

18 and older, any sex, with Death, Sudden, Cardiac. 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.

Cumulative First and Second Shock VT/VF Conversion Rate Primary · Through study procedure completion, average of 2 hours

The number of subjects with successful (first or second shock) arrhythmia conversion using the Test System divided by the total number of inductions attempted using the Test System A successful arrhythmia conversion is defined as termination of an induced ventricular rhythm by first or second shock from the Test System to a non-shockable rhythm (rhythms other than VT or VF).

Group	Value	95% CI
Per-Protocol	100	73.5 – 100
Intention-to-Treat	100	75.3 – 100

First Shock VT/VF Conversion Rate Secondary · Through study procedure completion, average of 2 hours

The number of subjects with successful (first shock) arrhythmia conversion using the Test System divided by the total number of inductions attempted with using the Test System A successful arrhythmia conversion is defined as termination of an induced ventricular rhythm by first shock from the Test System to a non-shockable rhythm (rhythms other than VT or VF).

Group	Value	95% CI
Per-Protocol	83.3	51.6 – 97.9
Intention-to-Treat	84.6	54.6 – 98.1

Adverse events — posted to ClinicalTrials.gov

Time frame: During the study procedure or observed during clinical follow-up within one week post procedure.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Enrolled Subjects

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (1 terms — click to expand)

Reaction	System	Enrolled Subjects
Redness/Irritation (Anticipated Adverse Device Effect)	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT04132466 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Defibrillation effectiveness and safety of the shock waveform used in a contemporary wearable cardioverter defibrillator: Results from animal and human studies.
   Gleva MJ, Sullivan J, Crawford TC, Walcott G, et al · · 2023 · cited 2× · PMID 36917566 · DOI 10.1371/journal.pone.0281340