Trial Outcomes & Findings for ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (NCT NCT04132466)

Last Updated: 2024-04-05

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

Through study procedure completion, average of 2 hours

Results posted on

2024-04-05

Participant Flow

Thirteen (13) patients were enrolled at two investigational sites between November 25, 2019 and March 19, 2020. In consult with the FDA, enrollment was stopped short of the target enrollment of 20 patients due to the COVID-19 outbreak.

Participant milestones

Participant milestones
Measure	Enrolled Subjects Adult subjects who met eligibility criteria and provided written informed consent to participate Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system: defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ASSURE WCD Clinical Evaluation - Conversion Efficacy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrolled Subjects n=13 Participants Adult subjects who met eligibility criteria and provided written informed consent to participate Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system: defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator
Age, Continuous	55.3 years STANDARD_DEVIATION 11.3 • n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Race (NIH/OMB) White	10 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	13 participants n=99 Participants

PRIMARY outcome

Timeframe: Through study procedure completion, average of 2 hours

Population: In consult with FDA, enrollment was halted due to the COVID pandemic after 13 subjects were enrolled. The study procedure was completed on all 13 subjects, which comprised the Intention-to-Treat cohort. Study monitoring identified one subject had been prescribed Amiodarone during an emergency room visit (three weeks prior to study enrollment) and continued taking it for 6 days (protocol eligibility deviation). Twelve patients were therefore included in the Per Protocol cohort.

Outcome measures

Outcome measures
Measure	Per-Protocol n=12 Participants Adult subjects who met eligibility criteria and provided written informed consent to participate Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system: defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator	Intention-to-Treat n=13 Participants All subjects enrolled
Cumulative First and Second Shock VT/VF Conversion Rate	100 percentage Interval 73.5 to 100.0	100 percentage Interval 75.3 to 100.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Per-Protocol n=12 Participants Adult subjects who met eligibility criteria and provided written informed consent to participate Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system: defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator	Intention-to-Treat n=13 Participants All subjects enrolled
First Shock VT/VF Conversion Rate	83.3 percentage Interval 51.6 to 97.9	84.6 percentage Interval 54.6 to 98.1

Adverse Events

Enrolled Subjects

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Enrolled Subjects n=13 participants at risk Adult subjects who met eligibility criteria and provided written informed consent to participate Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system: defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator
Skin and subcutaneous tissue disorders Redness/Irritation (Anticipated Adverse Device Effect)	23.1% 3/13 • Number of events 3 • During the study procedure or observed during clinical follow-up within one week post procedure. Adverse events in this study were limited to adverse device effects (ADEs). An ADE was defined as any untoward medical occurrence in a subject during the study that in the opinion of the investigator is at least possibly related to use of the Test System during the study procedure. Anticipated adverse device effects were specified in the study protocol based on risk assessment.

Additional Information

Laura Gustavson

Kestra Medical Technologies, Inc.

Phone: 14255264759

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place