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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04132466
Recruitment Status : Recruiting
First Posted : October 18, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Regulatory and Clinical Research Institute Inc
Information provided by (Responsible Party):
Kestra Medical Technologies, Inc.

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

Condition or disease Intervention/treatment Phase
Death, Sudden, Cardiac Device: ACE-CONVERT Study Test System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Multicenter single arm open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)
Actual Study Start Date : November 25, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Treatment
Adult cardiac patients who meet eligibility criteria
Device: ACE-CONVERT Study Test System
defibrillation




Primary Outcome Measures :
  1. Cumulative first and second shock VT/VF conversion rate [ Time Frame: Through study procedure completion, average of 2 hours ]
    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 :
  1. First shock VT/VF conversion rate [ Time Frame: Through study procedure completion, average of 2 hours ]
    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).


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132466


Contacts
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Contact: RON ROWBOTHAM, MSc 425-526-4913 ron.rowbotham@kestramedical.com
Contact: Laura Gustavson 425-526-4759 laura.gustavson@kestramedical.com

Locations
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United States, Alaska
Alaska Cardiovascular Research Foundation, Inc. Recruiting
Anchorage, Alaska, United States, 99508
Contact: Linda C Berg, RN    907-550-2283    lberg@alaskaheart.com   
Contact: Deidre Rambur    907-264-5860    drambur@alaskaheart.com   
Principal Investigator: Mark Willcox, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Sangeeta Lathkar-Pradhan, MBBS    734-232-5022    slathkar@med.umich.edu   
Contact: Rachel Wessel    7346152680    mbred@med.umich.edu   
Principal Investigator: Thomas Crawford, MD         
United States, Missouri
Washington University St Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Janice U Amsler, RN MSN    314-747-8542    jamslere@wustl.edu   
Contact: Jean Flanagan, RN MSN    314-4547451    jflanaga@wustl.edu   
Principal Investigator: Marye Gleva, MD         
United States, Washington
Institute for Research and Innovation MultiCare Health System Recruiting
Tacoma, Washington, United States, 98405
Contact: Janey Barnhart, RN CNRN    253-403-7258    mbarnhart@multicare.org   
Contact: Tiffany Edwards    253-403-7258    tdedwards@multicare.org   
Principal Investigator: Tariq Salam, MD         
Sponsors and Collaborators
Kestra Medical Technologies, Inc.
Regulatory and Clinical Research Institute Inc
Investigators
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Principal Investigator: Marye Gleva, MD Washington University School of Medicine

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Responsible Party: Kestra Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT04132466    
Other Study ID Numbers: 3333934_C
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Death, Sudden
Death
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases