Cardiac Arrest, SuddenACE-DETECTNCT03887052
ASSURE WCD Clinical Evaluation - Detection and Safety Study
A study testing ASSURE™ Wearable Cardioverter Defibrillator (WCD) in people with Cardiac Arrest, Sudden, run by Kestra Medical Technologies, Inc. at 10 sites in United States.
Trial summary
A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Sudden
- What is being tested?
- ASSURE™ Wearable Cardioverter Defibrillator (WCD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 10 sitesUnited States
- Study dates
- 20 Mar 2019to 18 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, age ≥ 18 years
- Patients with an active Implantable Cardioverter Defibrillator (ICD)
- Left Ventricular Ejection Fraction (LVEF) ≤ 40%, measured within the past year (12 months) by echocardiography, nuclear imaging (including MRI), or left ventricular angiography
- Able and willing to provide written informed consent before undergoing any study-related procedures
Who cannot join
- Any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements, including cognitive and/or physical limitations that would prevent the subject from interacting with the device as intended
- Any known skin allergy or sensitivity to the study garment materials that will be next to the skin
- Any breached or compromised skin on the upper body that would be exacerbated by wearing the study garment
- Work with or are frequently around equipment that produces high electromagnetic fields, for example magnetic resonance imaging devices, power supply facilities, or welding equipment
- Any planned surgical or medical procedures during the participation period that would require the subject to remove the study device for more than 12 hours
- Any planned air travel during the participation period
Show all 13Show fewer
- Pregnancy
- Use of mechanical circulatory support, including but not limited to Left Ventricular Assist Device (LVAD) or Total Artificial Heart
- Implanted Cardiac Resynchronization Therapy Defibrillator (CRT-D)
- Simultaneous plan/prescription for Holter monitor, mobile cardiac outpatient telemetry (MCOT), Event Recorder, or in-hospital telemetry
- Use of any electronic medical device that is worn on or near the body requires Sponsor approval, other than continuous positive airway pressure (CPAP), continuous blood glucose monitor, or pulse oximeter oxygen saturation (SpO2) monitor.
- Under bust chest circumference greater than 52 inches or less than 28 inches
- Current hospital inpatient
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Alaska Cardiovascular Research Foundation
Anchorage, Alaska, 99508
University of Michigan
Ann Arbor, Michigan, 48109
Cooper University Health Care
Camden, New Jersey, 08103
Heart Clinic of Hammond, LA
Hammond, Louisiana, 70403
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington Medical Center
Seattle, Washington, 98195
Washington University St Louis
St Louis, Missouri, 63110
Institute for Research and Innovation MultiCare Health System
Tacoma, Washington, 98405
Washington Adventist Hospital
Takoma Park, Maryland, 20912
Toledo ProMedica Hospital
Toledo, Ohio, 43615
About this study
Official title: ASSURE WCD Clinical Evaluation - Detection and Safety Study (ACE-DETECT)
A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD).
Read the detailed description
A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD). A total of 130 adult subjects at risk for sudden cardiac arrest but otherwise protected by an Implantable Cardioverter Defibrillator (ICD) will be enrolled at 10 clinical sites in the United States. Subjects will wear the device for approximately 30 days during normal daily activities including sleep. The WCD shock alarms and shock functionality will be disabled. Shock Alarm Event Markers are recorded by the WCD and will be used for analysis of the primary outcome measure. All episodes recorded by the ASSURE WCD and/or the subject's ICD will be reviewed by independent clinical experts.
- Conditions
- Cardiac Arrest, Sudden
- Being tested
- ASSURE™ Wearable Cardioverter Defibrillator (WCD)
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASSURE™ Wearable Cardioverter Defibrillator (WCD)Device
WCD with shock alarms and shock functionality disabled
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Adult cardiac patients at risk for sudden cardiac arrest otherwise protected with an Implantable Cardioverter Defibrillator (ICD) Receives: Device: ASSURE™ Wearable Cardioverter Defibrillator (WCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
WCD False Positive Alarm Rate
False Shock Alarms per patient day
Measured: 30 days
Secondary outcomes (2)
WCD True Positive Detections
WCD recorded episodes annotated as VT or VF
Measured: 30 days
WCD Missed Events
WCD False Negative Detections
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start20 Mar 2019
- Primary completion18 Jun 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest, SuddenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter single arm open label evaluation
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kestra Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regulatory and Clinical Research Institute Inc
- Responsible party
- Sponsor
- Investigators
- Jeanne E. Poole, MD, Principal investigator, University of Washington Medical Center, Seattle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887052
- Sponsor's protocol ID
- 3324582_B
- Acronym
- ACE-DETECT
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2019
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Poole JE, Gleva MJ, Birgersdotter-Green U, Branch KRH, Doshi RN, Salam T, Crawford TC, Willcox ME, Sridhar AM, Mikdadi G, Beinart SC, Cha YM, Russo AM, Rowbotham RK, Sullivan J, Gustavson LM, Kivilaid K. A wearable cardioverter defibrillator with a low false alarm rate. J Cardiovasc Electrophysiol. 2022 May;33(5):831-842. doi: 10.1111/jce.15417. Epub 2022 Feb 28.
PubMed 35174572
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSURE WCD Clinical Evaluation - Detection and Safety Study (ACE-DETECT)
- ClinicalTrials.gov ID
- NCT03887052
- Acronym / sponsor ID
- ACE-DETECT / 3324582_B
- Conditions
- Cardiac Arrest, Sudden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Kestra Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Regulatory and Clinical Research Institute Inc
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Posted 26 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD).
Detailed description
A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD). A total of 130 adult subjects at risk for sudden cardiac arrest but otherwise protected by an Implantable Cardioverter Defibrillator (ICD) will be enrolled at 10 clinical sites in the United States. Subjects will wear the device for approximately 30 days during normal daily activities including sleep. The WCD shock alarms and shock functionality will be disabled. Shock Alarm Event Markers are recorded by the WCD and will be used for analysis of the primary outcome measure. All episodes recorded by the ASSURE WCD and/or the subject's ICD will be reviewed by independent clinical experts.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter single arm open label evaluation
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Device: ASSURE™ Wearable Cardioverter Defibrillator (WCD)Adult cardiac patients at risk for sudden cardiac arrest otherwise protected with an Implantable Cardioverter Defibrillator (ICD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females, age ≥ 18 years
- Patients with an active Implantable Cardioverter Defibrillator (ICD)
- Left Ventricular Ejection Fraction (LVEF) ≤ 40%, measured within the past year (12 months) by echocardiography, nuclear imaging (including MRI), or left ventricular angiography
- Able and willing to provide written informed consent before undergoing any study-related procedures
Key exclusion criteria (13 listed)
- Any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements, including cognitive and/or physical limitations that would prevent the subject from interacting with the device as intended
- Any known skin allergy or sensitivity to the study garment materials that will be next to the skin
- Any breached or compromised skin on the upper body that would be exacerbated by wearing the study garment
- Work with or are frequently around equipment that produces high electromagnetic fields, for example magnetic resonance imaging devices, power supply facilities, or welding equipment
- Any planned surgical or medical procedures during the participation period that would require the subject to remove the study device for more than 12 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASSURE™ Wearable Cardioverter Defibrillator (WCD)WCD with shock alarms and shock functionality disabled | Device | Study Arm |
Primary outcome
WCD False Positive Alarm Rate
Time frame: 30 days
False Shock Alarms per patient day
2 secondary outcomes
WCD True Positive Detections
Time frame: 30 days
WCD Missed Events
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35174572Poole JE, Gleva MJ, Birgersdotter-Green U, Branch KRH, Doshi RN, Salam T, Crawford TC, Willcox ME, Sridhar AM, Mikdadi G, Beinart SC, Cha YM, Russo AM, Rowbotham RK, Sullivan J, Gustavson LM, Kivilaid K. A wearable cardioverter defibrillator with a low false alarm rate. J Cardiovasc Electrophysiol. 2022 May;33(5):831-842. doi: 10.1111/jce.15417. Epub 2022 Feb 28.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrest, Sudden
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruitingObservational study
Cardiovascular Pre-participation Screening in Children and Adolescents
Sudden Cardiac Death, Cardiac Arrhythmias
Recruiting
Speed-up the Diagnosis and Evaluation of anoMalous Coronary ARTery From the Aorta
AAOCA, ACAOS
RecruitingObservational study
Hypertrophic Cardiomyopathy Registry, Biobank and Imaging Data Repository
Hypertrophic Cardiomyopathy, Hypertrophic Obstructive Cardiomyopathy
RecruitingPhase 4
Epinephrine Dose: Optimal Versus Standard Evaluation Trial
Cardiac Arrest, Out-Of-Hospital, Sudden Cardiac Arrest
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne E. Poole, MD principal investigator
University of Washington Medical Center, Seattle
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASSURE™ Wearable Cardioverter Defibrillator (WCD) in people with Cardiac Arrest, Sudden, run by Kestra Medical Technologies, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WCD False Positive Alarm Rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03887052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.