Clinical trial NCT04132466: ASSURE WCD Clinical Evaluation - Conversion Efficacy Study
Official title: ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Death, Sudden, Cardiac
Lead sponsor: Kestra Medical Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Regulatory and Clinical Research Institute Inc
First posted: 2019-10-18
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter single arm open label
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Cumulative First and Second Shock VT/VF Conversion Rate
timeFrame: Through study procedure completion, average of 2 hours
Secondary outcomes:
measure: First Shock VT/VF Conversion Rate
timeFrame: Through study procedure completion, average of 2 hours
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Cardiovascular Research Foundation, Inc.
state: Alaska
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University St Louis
state: Missouri
city: Tacoma
country: United States
facility: Institute for Research and Innovation MultiCare Health System
state: Washington
Study officials:
affiliation: Washington University School of Medicine
name: Marye Gleva, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.