ArrhythmiaPhase 4NCT00187239
Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search Study
A Phase 4 study testing Autointrinsic Conduction Search Algorithm in people with Arrhythmia, run by Abbott Medical Devices at 1 site in United States.
Trial summary
The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM) implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction Search (AICS) rather than only a programmed AV/PV delay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Autointrinsic Conduction Search Algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Aug 2007
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has been implanted with a dual chamber SJM ICD with AICS for 1 month (± 2 weeks).
- At the time of enrollment, patient is paced in the right ventricle (RV) ≤25% of the time as determined by the device diagnostics.
- Patient is medically stable.
Who cannot join
- Patient has evidence of atrioventricular (AV) block (first, second or third degree) such that ventricular pacing would be required as part of the patient's routine management
- Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
- Patient is younger than 18 years of age.
- Patient is pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
AtlantiCare Regional Medical Center
Pomona, New Jersey
About this study
Official title: Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)
The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM) implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction Search (AICS) rather than only a programmed AV/PV delay. This study will compare the two methods of programming with respect to intrinsic activity.
- Conditions
- Arrhythmia
- Being tested
- Autointrinsic Conduction Search Algorithm
- Keywords
- ICDs, Ventricular pacing, Patient has been implanted with a dual chamber SJM ICD with AICS for 1 month (± 2 weeks)., At the time of enrollment, patient is paced in the RV ≤25% of the time as determined by the device diagnostics., Patient is medically stable.
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autointrinsic Conduction Search AlgorithmDevice
Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.
| Study group | Role | What they receive |
|---|---|---|
| AICS On | Active comparator | Patients in this arm have Autointrinsic conduction search programmed ON. Receives: Device: Autointrinsic Conduction Search Algorithm |
| AICS Off | No intervention | Patients assigned to this arm do not have Autointrinsic Conduction Search programmed on. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the percentage of intrinsic ventricular events.
Measured: 3 months
Secondary outcomes (4)
Number of atrial tachycardia (AT), atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) episodes
Measured: 3 months
Frequency of inappropriate ICD therapy during AT/AF
Measured: 3 months
Frequency of appropriate ICD therapy for VT/VF
Measured: 3 months
Study related adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionAug 2007
- Study completionAug 2007
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Zaffer Syed, MS, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187239
- Sponsor's protocol ID
- CRD292
- Status last verified
- Feb 2019
- First submitted
- 10 Sep 2005
- Last updated
- 4 Feb 2019
- Results posted
- 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
- Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)
- ClinicalTrials.gov ID
- NCT00187239
- Acronym / sponsor ID
- CRD292
- Conditions
- Arrhythmia
- Keywords
- ICDs, Ventricular pacing, Patient has been implanted with a dual chamber SJM ICD with AICS for 1 month (± 2 weeks)., At the time of enrollment, patient is paced in the RV ≤25% of the time as determined by the device diagnostics., Patient is medically stable.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 16 Sep 2005 (estimated)
- 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 purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM) implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction Search (AICS) rather than only a programmed AV/PV delay. This study will compare the two methods of programming with respect to intrinsic activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AICS On | Active comparator | Device: Autointrinsic Conduction Search AlgorithmPatients in this arm have Autointrinsic conduction search programmed ON. |
| AICS Off | No intervention | –Patients assigned to this arm do not have Autointrinsic Conduction Search programmed on. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has been implanted with a dual chamber SJM ICD with AICS for 1 month (± 2 weeks).
- At the time of enrollment, patient is paced in the right ventricle (RV) ≤25% of the time as determined by the device diagnostics.
- Patient is medically stable.
Key exclusion criteria (4 listed)
- Patient has evidence of atrioventricular (AV) block (first, second or third degree) such that ventricular pacing would be required as part of the patient's routine management
- Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
- Patient is younger than 18 years of age.
- Patient is pregnant.
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 |
|---|---|---|
| Autointrinsic Conduction Search AlgorithmAutointrinsic conduction search is programmed on in those patients randomized to AICS ON. | Device | AICS On |
Primary outcome
The primary endpoint is the percentage of intrinsic ventricular events.
Time frame: 3 months
4 secondary outcomes
Number of atrial tachycardia (AT), atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) episodes
Time frame: 3 months
Frequency of inappropriate ICD therapy during AT/AF
Time frame: 3 months
Frequency of appropriate ICD therapy for VT/VF
Time frame: 3 months
Study related adverse events
Time frame: 3 months
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 4 Feb 2019.
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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.
Zaffer Syed, MS study director
Abbott Medical Devices
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Autointrinsic Conduction Search Algorithm in people with Arrhythmia, 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 3 inclusion and 4 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary endpoint is the percentage of intrinsic ventricular events. (time frame: 3 months). 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.