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| Name | Class |
|---|---|
| Regulatory and Clinical Research Institute Inc | OTHER |
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A multicenter single arm open label evaluation of the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform in adult cardiac patients
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enrolled Subjects | Experimental | Adult subjects who met eligibility criteria and provided written informed consent to participate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system | Device | defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Through study procedure completion, average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Through study procedure completion, average of 2 hours |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marye Gleva, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Cardiovascular Research Foundation, Inc. | Anchorage | Alaska | 99508 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36917566 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage | Through study procedure completion, average of 2 hours |
|
During the study procedure or observed during clinical follow-up within one week post procedure.
Adverse events in this study were limited to adverse device effects (ADEs). An ADE was defined as any untoward medical occurrence in a subject during the study that in the opinion of the investigator is at least possibly related to use of the Test System during the study procedure. Anticipated adverse device effects were specified in the study protocol based on risk assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness/Irritation (Anticipated Adverse Device Effect) | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild skin irritation and redness in the location of the defibrillation pads within 48 hours following the procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Gustavson | Kestra Medical Technologies, Inc. | 14255264759 | laura.gustavson@kestramedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2019 | Mar 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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Multicenter single arm open label
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| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Washington University St Louis | St Louis | Missouri | 63110 | United States |
| Institute for Research and Innovation MultiCare Health System | Tacoma | Washington | 98405 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Per-Protocol |
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 |
| OG001 | Intention-to-Treat | All subjects enrolled |
|
|
| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage | Through study procedure completion, average of 2 hours |
|
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|
| 0 |
| 13 |
| 0 |
| 13 |
| 3 |
| 13 |
|
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| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |