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

Kestra Medical Technologies

Status: Completed

Conditions: Death, Sudden, Cardiac

Treatments: Device: Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04132466

3333934_C

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Enrolled Subjects

Experimental group

Description:

Adult subjects who met eligibility criteria and provided written informed consent to participate

Treatment:

Device: Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system