TachyarrhythmiasNCT00940888
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
An observational study of Tachyarrhythmias and Sudden Cardiac Death, run by Abbott Medical Devices at 1 site in United States.
Trial summary
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachyarrhythmias, Sudden Cardiac Death, Heart Failure
- What is being tested?
- SJ4 connector and RV high voltage SJ4 lead
- Type of treatment
- Medical device
- How many people
- 1,701 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2015
- Phase
- Observational
- 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
Study population: ICD and CRTD indicated patients
Who may be able to join
- Have an approved indication per ACC/AHA/HRS guidelines for implantation of heart failure or life-threatening ventricular tachyarrhythmias and will be implanted with a St. Jude Medical SJ4 system.
- Have the ability to provide informed consent for study participating and be willing and able to comply with the prescribed follow-up test and schedule of evaluations.
Who cannot join
- Be currently participating in a clinical investigation that includes an active treatment arm.
- Have a life expectancy of less than 6 months due to any condition.
- Be less than 18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this study
Official title: SJ4 Post Approval Study
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
- Conditions
- Tachyarrhythmias, Sudden Cardiac Death, Heart Failure
- Being tested
- SJ4 connector and RV high voltage SJ4 lead
- Keywords
- ICD, CRTD, Heart Failure, DF4
- Medical subject headings
- Tachycardia, Death, Sudden, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SJ4 connector and RV high voltage SJ4 leadDevice
Standard of care implantation of SJ4 device system
| Study group | Role | What they receive |
|---|---|---|
| No treatment: ICD/CRTD-indicated | Not described Receives: Device: SJ4 connector and RV high voltage SJ4 lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right Ventricle (RV) Bipolar Capture Thresholds
Measured: 5 years
Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2015
- Study completionDec 2015
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.
- Other trials for TachyarrhythmiasStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- 1,701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Wilkoff, MD, Principal investigator, The Clevleland Clinic Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940888
- Sponsor's protocol ID
- 60020938
- Status last verified
- Jan 2019
- First submitted
- 14 Jul 2009
- Last updated
- 4 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SJ4 Post Approval Study
- ClinicalTrials.gov ID
- NCT00940888
- Acronym / sponsor ID
- 60020938
- Conditions
- Tachyarrhythmias, Sudden Cardiac Death, Heart Failure
- Keywords
- ICD, CRTD, Heart Failure, DF4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,701 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Jul 2009 (estimated)
- Results
- Posted 14 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment: ICD/CRTD-indicated | – | Device: SJ4 connector and RV high voltage SJ4 lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICD and CRTD indicated patients
Key inclusion criteria (2 listed)
- Have an approved indication per ACC/AHA/HRS guidelines for implantation of heart failure or life-threatening ventricular tachyarrhythmias and will be implanted with a St. Jude Medical SJ4 system.
- Have the ability to provide informed consent for study participating and be willing and able to comply with the prescribed follow-up test and schedule of evaluations.
Key exclusion criteria (3 listed)
- Be currently participating in a clinical investigation that includes an active treatment arm.
- Have a life expectancy of less than 6 months due to any condition.
- Be less than 18 years of age.
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 |
|---|---|---|
| SJ4 connector and RV high voltage SJ4 leadStandard of care implantation of SJ4 device system | Device | No treatment: ICD/CRTD-indicated |
Primary outcome
Right Ventricle (RV) Bipolar Capture Thresholds
Time frame: 5 years
Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Bruce Wilkoff, MD principal investigator
The Clevleland Clinic Foundation
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 Tachyarrhythmias and Sudden Cardiac Death, run by Abbott Medical Devices 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 2 inclusion and 3 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 4 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 14 Aug 2017). 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?
Right Ventricle (RV) Bipolar Capture Thresholds (time frame: 5 years). The study lists 2 primary outcomes in all. 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 4 Feb 2019.