ASSURE WCD Clinical Evaluation - Conver… | Clinical Trial

Key information

Conditions

Death, Sudden, Cardiac Cardiovascular Diseases Death Death, Sudden Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alaska Cardiovascular Research Foundation, Inc., Anchorage, Alaska, United States

About this study

The objective of this study is to evaluate Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) conversion efficacy in adult human subjects using the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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

Treatment and study plan

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

Device

defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator

Primary outcomes

Cumulative First and Second Shock VT/VF Conversion Rate

Time frame: 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).

Secondary outcomes

First Shock VT/VF Conversion Rate

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Kestra Medical Technologies, Inc.

Industry

Collaborators

Regulatory and Clinical Research Institute Inc

Registry information

Official study title

ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)

Acronym: ACE-CONVERT

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Oct 18, 2019
Registry last updated: Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed