Status:
COMPLETED
ASSURE WCD Clinical Evaluation - Conversion Efficacy Study
Lead Sponsor:
Kestra Medical Technologies, Inc.
Collaborating Sponsors:
Regulatory and Clinical Research Institute Inc
Conditions:
Death, Sudden, Cardiac
Eligibility:
All Genders
18+ years
Phase:
NA
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 (WC...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- Amiodarone use within 3 months before the study procedure
Key Trial Info
Start Date :
November 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04132466
Start Date
November 25 2019
End Date
March 19 2020
Last Update
April 5 2024
Active Locations (4)
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1
Alaska Cardiovascular Research Foundation, Inc.
Anchorage, Alaska, United States, 99508
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
3
Washington University St Louis
St Louis, Missouri, United States, 63110
4
Institute for Research and Innovation MultiCare Health System
Tacoma, Washington, United States, 98405