ArrhythmiaASC ICD RegNCT03604133
Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
An observational study of Arrhythmia, run by QuesGen Systems Inc at 1 site in United States.
Trial summary
The primary objectives for the registry is to evaluate the overall incidence of serious complications or adverse events for primary implants and replacement devices, and assess the cost and time efficiency for both physicians and patients. The Registry is a multi ASC data collection registry. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arrhythmia
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2017to 24 Aug 2028
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals who require ICD to maintain optimal health.
Who may be able to join
- Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC)
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cardio Surgical Partners, LLC
Lehi, Utah, 84043
Michael Dutton, 801-358-4231, mdutton@cardiosp.com
About this study
The primary objectives for the registry is to evaluate the overall incidence of serious complications or adverse events for primary implants and replacement devices, and assess the cost and time efficiency for both physicians and patients. The Registry is a multi ASC data collection registry. Data collection will occur at the time of screening, implant, and 2 weeks after implant at the time of wound check.
- Conditions
- Arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving ICD devices | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Implantation
Patient undergoes surgery for ICD device implantation
Measured: Two-week follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start24 Aug 2017
- Primary completion24 Aug 2023 (estimated)
- Study completion24 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- QuesGen Systems Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Cardio Surgical Partners
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604133
- Sponsor's protocol ID
- 2018-310 Cardiac Registry
- Acronym
- ASC ICD Reg
- Status last verified
- Jan 2021
- First submitted
- 18 Jul 2018
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
- ClinicalTrials.gov ID
- NCT03604133
- Acronym / sponsor ID
- ASC ICD Reg / 2018-310 Cardiac Registry
- Conditions
- Arrhythmia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- QuesGen Systems IncUniversity, hospital or other
- Collaborators
- Cardio Surgical Partners
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 24 Aug 2023 (estimated)
- Study completion
- 24 Aug 2028 (estimated)
- First posted
- 27 Jul 2018 (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.
The primary objectives for the registry is to evaluate the overall incidence of serious complications or adverse events for primary implants and replacement devices, and assess the cost and time efficiency for both physicians and patients. The Registry is a multi ASC data collection registry. Data collection will occur at the time of screening, implant, and 2 weeks after implant at the time of wound check.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving ICD devices | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals who require ICD to maintain optimal health.
Key inclusion criteria (1 listed)
- Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC)
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful Implantation
Time frame: Two-week follow-up assessment
Patient undergoes surgery for ICD device implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia, run by QuesGen Systems Inc at 1 site 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Jarrett, MBA (415-608-3570, mike.jarrett@quesgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Implantation (time frame: Two-week follow-up assessment). 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 22 Jan 2021.