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

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

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

Study Overview

• Status: Completed
• Conditions: Death, Sudden, Cardiac
• Intervention / Treatment: Device: Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Cardiovascular Research Foundation, Inc.
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University St Louis
  • Washington
    • Tacoma, Washington, United States, 98405
      • Institute for Research and Innovation MultiCare Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enrolled Subjects; Adult subjects who met eligibility criteria and provided written informed consent to participate	Device: Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system; defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative First and Second Shock VT/VF Conversion Rate	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).	Through study procedure completion, average of 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Shock VT/VF Conversion Rate	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).	Through study procedure completion, average of 2 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Summary of adverse events that in the judgement of the investigator are at least possibly related to use of the investigational Test System.	Through study procedure completion, average of 2 hours

Collaborators and Investigators

• Sponsor: Kestra Medical Technologies, Inc.
• Collaborators: Regulatory and Clinical Research Institute Inc
• Investigators: Principal Investigator: Marye Gleva, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• Gleva MJ, Sullivan J, Crawford TC, Walcott G, Birgersdotter-Green U, Branch KR, Doshi RN, Kivilaid K, Brennan K, Rowbotham RK, Gustavson LM, Poole JE. Defibrillation effectiveness and safety of the shock waveform used in a contemporary wearable cardioverter defibrillator: Results from animal and human studies. PLoS One. 2023 Mar 14;18(3):e0281340. doi: 10.1371/journal.pone.0281340. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): March 19, 2020
• Study Completion (Actual): March 19, 2020

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death; Heart Arrest; Death, Sudden, Cardiac; Death, Sudden
• Other Study ID Numbers: 3333934_C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes