Recruiting

Observational Study

Sponsor:

Kestra Medical Technologies, Inc.

Code:

NCT05135403

Conditions

Sudden Cardiac Arrest

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Defibrillation

Study Details

Brief summary:

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.

Conditions

Sudden Cardiac Arrest

Study ID

NCT05135403

Start date

Nov 20, 2021

Status verified date

Aug, 2025

Completion date

Oct 1, 2025

Anticipated

Primary completion date

Oct 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patient prescribed the ASSURE wearable cardioverter defibrillator
  • Provided written informed consent to participate in the ASSURE Patient Registry

Exclusion Criteria:

  • Patients who do not meet the Inclusion criteria

Study Design

Enrollment

5179 participants

Anticipated

Interventions and Outcome Measures

Arms

ASSURE Registry Patients

Patient prescribed the ASSURE WCD who have also consented to participate in the ASSURE Patient Registry. Patients include those with reduced left ventricular ejection fraction (LVEF) and recent myocardial infarction, recent coronary revascularization, or new onset heart failure (HF) to allow for optimization of medical therapy and re-evaluation of cardiac function. Additional indications include ICD explant due to infection, postponed ICD implant, and pending heart transplant.

Interventions

Defibrillation

External defibrillation from a wearable cardioverter defibrillator

Primary outcome measure

  • Overall shock conversion rate [ Time Frame: Up to 3 years ]
  • Inappropriate shocks per patient month [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Kristin Eis, BSChE, MBA

14256547596kristin.eis@kestramedical.com

Locations

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98033

Contacts

Kristin Eis, BSChE, MBA

12069636044kristin.eis@kestramedical.com

More Information

Sponsor

Kestra Medical Technologies, Inc.

Last update posted

Sep 2, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kestra Medical Technologies, Inc. on 2025-09-02.