N/A
Completed N=13
ASSURE WCD Clinical Evaluation - Conversion Efficacy Study
Death, Sudden, Cardiac
Source: ClinicalTrials.gov NCT04132466 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Cumulative First and Second Shock VT/VF Conversion Rate — 100; 100 percentage
Summary
A multicenter single arm open label evaluation of the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform in adult cardiac patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative First and Second Shock VT/VF Conversion Rate |
100; 100 | — |
| SECONDARY First Shock VT/VF Conversion Rate |
83.3; 84.6 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04132466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.