ASSURE WCD Clinical Evaluation - Conversion Efficacy Study

NCT04132466 | Completed Results FDA Device

• 1 other identifier: 3333934_C
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Death, Sudden, Cardiac

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• First Shock VT/VF Conversion Rate

  Through study procedure completion, average of 2 hours

Study Arms (1)

Enrolled Subjects

EXPERIMENTAL

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

Interventions

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

Enrolled Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Kestra Medical Technologies, Inc.: lead
• Regulatory and Clinical Research Institute Inc: collaborator

Study Sites (4)

Alaska Cardiovascular Research Foundation, Inc.

Anchorage, Alaska, 99508, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University St Louis

St Louis, Missouri, 63110, United States

Location

Institute for Research and Innovation MultiCare Health System

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• 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.

  PMID: 36917566 RESULT

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Laura Gustavson
• Organization: Kestra Medical Technologies, Inc.

laura.gustavson@kestramedical.com

14255264759

Study Officials

• Marye Gleva, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter single arm open label

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 18, 2019
• Study Start: November 25, 2019
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: April 5, 2024
• Results First Posted: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)