Cardiac ArrestNCT04014842
RapidShock Post-Approval Study
A study testing RapidShock in people with Cardiac Arrest, run by Zoll Medical Corporation at 7 sites in United States.
Trial summary
Compare the performance of the Reconfirmation Analysis Mode algorithm to the performance goals recommended by the American Heart Association. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- RapidShock
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,756 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Feb 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 8 years of age or older and weight ≥ 55 lbs (25 kgs)
- Out-of-hospital cardiac arrest (OOHCA)
- Non-traumatic cardiac arrest
Who cannot join
- Weight less than 55 lbs (25 kgs)
- Do not attempt resuscitation (DNAR) orders
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
East Baton Rouge Parish EMS
Baton Rouge, Louisiana, 70807
Ventura County Fire Department
Camarillo, California, 93010
Colorado Springs Fire Department
Colorado Springs, Colorado, 80910
Detroit Fire Department
Detroit, Michigan, 48234
Fort Worth Fire Department
Fort Worth, Texas, 76115
M Health Fairview EMS
Saint Paul, Minnesota, 55106
San Antonio Fire
San Antonio, Texas, 78229
About this study
Official title: Post-Approval Study for Reconfirmation Analysis Mode Algorithm
Compare the performance of the Reconfirmation Analysis Mode algorithm to the performance goals recommended by the American Heart Association.
- Conditions
- Cardiac Arrest
- Being tested
- RapidShock
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapidShockDevice
Use of the Reconfirmation Analysis Mode algorithm
| Study group | Role | What they receive |
|---|---|---|
| RapidShock | Other | Patients receiving xseries device with rapid shock enabled Receives: Device: RapidShock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algorithm accuracy
Accuracy of the algorithm compared to manual annotation for each rhythm
Measured: average of up to 1 hour after device placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start26 Feb 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Masking
- None (open label)
- Enrolment
- 2,756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014842
- Sponsor's protocol ID
- 12701
- Status last verified
- Jul 2024
- First submitted
- 25 Apr 2019
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study for Reconfirmation Analysis Mode Algorithm
- ClinicalTrials.gov ID
- NCT04014842
- Acronym / sponsor ID
- 12701
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,756 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the performance of the Reconfirmation Analysis Mode algorithm to the performance goals recommended by the American Heart Association.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RapidShock | Other | Device: RapidShockPatients receiving xseries device with rapid shock enabled |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 8 years of age or older and weight ≥ 55 lbs (25 kgs)
- Out-of-hospital cardiac arrest (OOHCA)
- Non-traumatic cardiac arrest
Key exclusion criteria (2 listed)
- Weight less than 55 lbs (25 kgs)
- Do not attempt resuscitation (DNAR) orders
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 |
|---|---|---|
| RapidShockUse of the Reconfirmation Analysis Mode algorithm | Device | RapidShock |
Primary outcome
Algorithm accuracy
Time frame: average of up to 1 hour after device placement
Accuracy of the algorithm compared to manual annotation for each rhythm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RapidShock in people with Cardiac Arrest, run by Zoll Medical Corporation at 7 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 3 inclusion and 2 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Algorithm accuracy (time frame: average of up to 1 hour after device placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2024.