Death, Sudden, Cardiac
Conditions
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.
Interventions
DEVICEDefibrillation 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
Sponsors
Regulatory and Clinical Research Institute Inc
Kestra Medical Technologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter single arm open label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative First and Second Shock VT/VF Conversion Rate | Through study procedure completion, average of 2 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First Shock VT/VF Conversion Rate | Through study procedure completion, average of 2 hours | 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). |
Countries
United States
Participant flow
Recruitment details
Thirteen (13) patients were enrolled at two investigational sites between November 25, 2019 and March 19, 2020. In consult with the FDA, enrollment was stopped short of the target enrollment of 20 patients due to the COVID-19 outbreak.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Subjects Adult subjects who met eligibility criteria and provided written informed consent to participate
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 | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Enrolled Subjects |
|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 11.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 3 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
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).
Time frame: Through study procedure completion, average of 2 hours
Population: In consult with FDA, enrollment was halted due to the COVID pandemic after 13 subjects were enrolled. The study procedure was completed on all 13 subjects, which comprised the Intention-to-Treat cohort. Study monitoring identified one subject had been prescribed Amiodarone during an emergency room visit (three weeks prior to study enrollment) and continued taking it for 6 days (protocol eligibility deviation). Twelve patients were therefore included in the Per Protocol cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Per-Protocol | Cumulative First and Second Shock VT/VF Conversion Rate | 100 percentage |
| Intention-to-Treat | Cumulative First and Second Shock VT/VF Conversion Rate | 100 percentage |
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).
Time frame: Through study procedure completion, average of 2 hours
Population: In consult with FDA, enrollment was halted due to the COVID pandemic after 13 subjects were enrolled. The study procedure was completed on all 13 subjects, which comprised the Intention-to-Treat cohort. Study monitoring identified one subject had been prescribed Amiodarone during an emergency room visit (three weeks prior to study enrollment) and continued taking it for 6 days (protocol eligibility deviation). Twelve patients were therefore included in the Per Protocol cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Per-Protocol | First Shock VT/VF Conversion Rate | 83.3 percentage |
| Intention-to-Treat | First Shock VT/VF Conversion Rate | 84.6 percentage |