Death, Sudden, CardiacACE-CONVERTNCT04132466

ASSURE WCD Clinical Evaluation - Conversion Efficacy Study

A study testing Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system in people with Death, Sudden, Cardiac, run by Kestra Medical Technologies, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Death, Sudden, Cardiac
What is being tested?: Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 4 sitesUnited States
Study dates: 25 Nov 2019to 19 Mar 2020
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
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)

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Alaska Cardiovascular Research Foundation, Inc.
Anchorage, Alaska, 99508
University of Michigan
Ann Arbor, Michigan, 48109
Washington University St Louis
St Louis, Missouri, 63110
Institute for Research and Innovation MultiCare Health System
Tacoma, Washington, 98405

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Death, Sudden, Cardiac
Being tested: Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system
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.

Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test systemDevice
defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator

Study groups in NCT04132466
Study group	Role	What they receive
Enrolled Subjects	Experimental	Adult subjects who met eligibility criteria and provided written informed consent to participate Receives: Device: Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Through study procedure completion, average of 2 hours

Secondary outcomes (1)

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).
Measured: Through study procedure completion, average of 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Nov 201919 Mar 2020

First posted18 Oct 2019
Study start25 Nov 2019
Primary completion19 Mar 2020
Study completion19 Mar 2020

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 Death, Sudden, CardiacStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Multicenter single arm open label
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04132466
Sponsor's protocol ID: 3333934_C
Acronym: ACE-CONVERT
Status last verified: Apr 2024
First submitted: 15 Oct 2019
Last updated: 5 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 36917566

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)
ClinicalTrials.gov ID: NCT04132466
Acronym / sponsor ID: ACE-CONVERT / 3333934_C
Conditions: Death, Sudden, Cardiac
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Kestra Medical Technologies, Inc.Industry (pharma, biotech, devices)
Collaborators: Regulatory and Clinical Research Institute Inc
Study start: 25 Nov 2019 (actual)
Primary completion: 19 Mar 2020 (actual)
Study completion: 19 Mar 2020 (actual)
First posted: 18 Oct 2019 (actual)
Results: Posted 5 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Multicenter single arm open label

Arm	Type	Receives
Enrolled Subjects	Experimental	Device: Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test systemAdult subjects who met eligibility criteria and provided written informed consent to participate

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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:

Key exclusion criteria (16 listed)

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

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
Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test systemdefibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator	Device	Enrolled Subjects

Primary outcome

Cumulative First and Second Shock VT/VF Conversion Rate
Time frame: 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).

1 secondary outcome

First Shock VT/VF Conversion Rate
Time frame: Through study procedure completion, average of 2 hours

Results and safety

Results posted to the registry on 5 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enrolled Subjects	13	13

Primary outcome: Cumulative First and Second Shock VT/VF Conversion Rate

Time frame: Through study procedure completion, average of 2 hours. Number (95% Confidence Interval). Unit: percentage

Measure	Per-Protocol n = 12	Intention-to-Treat n = 13
Value	100 (73.5 to 100)	100 (75.3 to 100)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During the study procedure or observed during clinical follow-up within one week post procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enrolled Subjects	0 of 13 (0%)	3 of 13 (23.1%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36917566Gleva 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.
Individual participant dataSharing planned: No

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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.

Marye Gleva, MD principal investigator

Washington University School of Medicine

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 16 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 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 5 Apr 2024). 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?

Cumulative First and Second Shock VT/VF Conversion Rate (time frame: Through study procedure completion, average of 2 hours). 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 NCT04132466, 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 5 Apr 2024.