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

Primary Purpose

Death, Sudden, Cardiac

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system
Sponsored by
Kestra Medical Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Death, Sudden, Cardiac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males or females, age ≥ 18 years
  2. Able and willing to provide written informed consent before undergoing any study-related procedures

  3. Scheduled for any of the following procedures:

    1. Electrophysiology study for induction of ventricular arrhythmias
    2. Non-invasive electrophysiology testing using an existing implantable defibrillator
    3. Implantable cardioverter-defibrillator (ICD) replacement procedure during which induction of a ventricular arrhythmia is planned
    4. 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:

  1. Any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements
  2. Pregnancy
  3. Use of mechanical circulatory support (e.g. Left Ventricular Assist Device, Total Artificial Heart, intraaortic balloon pump or Impella)
  4. Documented nonchronic cardiac thrombus
  5. Atrial fibrillation or atrial flutter without therapeutic systemic anticoagulation
  6. Critical aortic stenosis
  7. Unstable coronary artery disease (CAD)
  8. Recent stroke or transient ischemic attack (TIA)
  9. Hemodynamic instability
  10. Currently implanted Boston Scientific S-ICD (due to location of implant relative to test system)
  11. Unstable angina
  12. New York Heart Association (NYHA) Class IV
  13. Left Ventricular Ejection Fraction (LVEF) < 20%
  14. 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
  15. History of difficulty of ventricular arrhythmia induction
  16. Amiodarone use within 3 months before the study procedure

Sites / Locations

  • Alaska Cardiovascular Research Foundation, Inc.
  • University of Michigan
  • Washington University St Louis
  • Institute for Research and Innovation MultiCare Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enrolled Subjects

Arm Description

Adult subjects who met eligibility criteria and provided written informed consent to participate

Outcomes

Primary Outcome Measures

Cumulative first and second shock VT/VF conversion rate
The ratio of the number of subjects with successful (first or second shock) arrhythmia conversion using the Test System to the number of total inductions attempted with shocks delivered by 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 Outcome Measures

First shock VT/VF conversion rate
The ratio of the number of subjects with successful (first shock) arrhythmia conversion using the Test System to the number of total inductions attempted with shocks delivered by 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).

Full Information

First Posted
October 15, 2019
Last Updated
September 1, 2021
Sponsor
Kestra Medical Technologies, Inc.
Collaborators
Regulatory and Clinical Research Institute Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04132466
Brief Title
ASSURE WCD Clinical Evaluation - Conversion Efficacy Study
Acronym
ACE-CONVERT
Official Title
ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
March 19, 2020 (Actual)
Study Completion Date
March 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kestra Medical Technologies, Inc.
Collaborators
Regulatory and Clinical Research Institute Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Death, Sudden, Cardiac

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multicenter single arm open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enrolled Subjects
Arm Type
Experimental
Arm Description
Adult subjects who met eligibility criteria and provided written informed consent to participate
Intervention Type
Device
Intervention Name(s)
Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system
Intervention Description
defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator
Primary Outcome Measure Information:
Title
Cumulative first and second shock VT/VF conversion rate
Description
The ratio of the number of subjects with successful (first or second shock) arrhythmia conversion using the Test System to the number of total inductions attempted with shocks delivered by 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).
Time Frame
Through study procedure completion, average of 2 hours
Secondary Outcome Measure Information:
Title
First shock VT/VF conversion rate
Description
The ratio of the number of subjects with successful (first shock) arrhythmia conversion using the Test System to the number of total inductions attempted with shocks delivered by 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).
Time Frame
Through study procedure completion, average of 2 hours
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Summary of adverse events that in the judgement of the investigator are at least possibly related to use of the investigational Test System.
Time Frame
Through study procedure completion, average of 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marye Gleva, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alaska Cardiovascular Research Foundation, Inc.
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Institute for Research and Innovation MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ASSURE WCD Clinical Evaluation - Conversion Efficacy Study

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