ASSURE WCD Clinical Evaluation - Conversion Efficacy Study

Completed · Not applicable

Conditions studied: Death, Sudden, Cardiac

In brief

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

Key facts

Study ID

NCT04132466

Run by

Kestra Medical Technologies, Inc.

People needed

13

Starts

2019-11-25

Expected to finish

2020-03-19

Last updated by the study team

2024-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females, age ≥ 18 years
• Able and willing to provide written informed consent before undergoing any study-related procedures
• Scheduled for any of the following procedures:
• Electrophysiology study for induction of ventricular arrhythmias
• Non-invasive electrophysiology testing using an existing implantable defibrillator
• Implantable cardioverter-defibrillator (ICD) replacement procedure during which induction of a ventricular arrhythmia is planned
• Ablation of ventricular tachycardia (patients undergoing ventricular tachycardia ablation in which only a substrate modification approach is planned, with no intention of inducing a ventricular arrhythmia, should not be included)

You may not qualify if…

• Any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements
• Pregnancy
• Use of mechanical circulatory support (e.g. Left Ventricular Assist Device, Total Artificial Heart, intraaortic balloon pump or Impella)
• Documented nonchronic cardiac thrombus
• Atrial fibrillation or atrial flutter without therapeutic systemic anticoagulation
• Critical aortic stenosis
• Unstable coronary artery disease (CAD)
• Recent stroke or transient ischemic attack (TIA)
• Hemodynamic instability
• Currently implanted Boston Scientific S-ICD (due to location of implant relative to test system)
• Unstable angina
• New York Heart Association (NYHA) Class IV
• Left Ventricular Ejection Fraction (LVEF) < 20%
• Any medical condition that by the judgement of the physician investigator, patient participation in this study is not in the best interest of the patient
• History of difficulty of ventricular arrhythmia induction
• Amiodarone use within 3 months before the study procedure

Where it is running

• Alaska Cardiovascular Research Foundation, Inc. — Anchorage, Alaska, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University St Louis — St Louis, Missouri, United States
• Institute for Research and Innovation MultiCare Health System — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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