Health TrialsbyHealthPanel

ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)

ConditionSudden Cardiac Arrest
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKestra Medical Technologies, Inc.

About this trial

Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patient prescribed the ASSURE wearable cardioverter defibrillator

Provided written informed consent to participate in the ASSURE Patient Registry

Disqualifiers

Patients who do not meet the Inclusion criteria

Trial population

The ASSURE Wearable Cardioverter Defibrillator (WCD) system is indicated for adult patients who are at risk or at perceived risk of sudden cardiac arrest (SCA) and are not immediate candidates for, or refuse, an implantable defibrillator.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Defibrillation

    Device

    External defibrillation from a wearable cardioverter defibrillator

Treatment groups

5,179 Participants
are divided into 1 treatment group
Group A: ASSURE Registry Patients1 intervention

Trial outcomes

Primary outcomes

1

Overall shock conversion rate

Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) successfully converted with one or more shocks ≥ 89.0%

Time frame
Up to 3 years
2

Inappropriate shocks per patient month

Total inappropriate shocks/cumulative months of WCD use for all patients ≤ 0.0075

Time frame
Up to 3 years

Secondary outcomes

1

First shock conversion rate

Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) converted with a single shock. (report only)

Time frame
Up to 3 years
2

Inappropriate shock rate

Percent of patients who experience at least one inappropriate shock (report only)

Time frame
Up to 3 years

Other outcomes

1

Appropriate shock rate per month

Number of appropriate shocks/cumulative months of WCD use

Time frame
Up to 3 years
2

Appropriate shock rate

Percent of patients who experience at least one appropriate shock

Time frame
Up to 3 years
3

Total Shocks delivered

Number of shocks delivered

Time frame
Up to 3 years
4

Shocks diverted

Number of shocks diverted by patients

Time frame
Up to 3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kestra Medical Technologies, Inc.

Lead sponsor

Source ClinicalTrials.gov
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