ASSURE WCD Clinical Evaluation - Conversion Efficacy Study

Death, Sudden, Cardiac Clinical Trial

— ACE-CONVERT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04132466
• Other study ID #: 3333934_C
• Status: Completed
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: March 19, 2020

Study information

• Verified date: April 2024
• Source: Kestra Medical Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death, Sudden
• Death, Sudden, Cardiac

Intervention

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

Locations

Country	Name	City	State
United States	Alaska Cardiovascular Research Foundation, Inc.	Anchorage	Alaska
United States	University of Michigan	Ann Arbor	Michigan
United States	Washington University St Louis	Saint Louis	Missouri
United States	Institute for Research and Innovation MultiCare Health System	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Kestra Medical Technologies, Inc.	Regulatory and Clinical Research Institute Inc

Country where clinical trial is conducted

United States, 

References & 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 cardiovert — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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