BradycardiaNCT00311168
Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)
A study testing Intervention/treatment in people with Bradycardia, run by Abbott Medical Devices at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with implanted SJM pacemakers will benefit by using VIP™ rather than only a programmed AV/PV delay. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bradycardia
- What is being tested?
- Intervention/treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Sep 2008
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has been implanted with dual chamber SJM Victory® device with VIP™ for 1 month (± 2 weeks).
- At the time of pacemaker implant, VIP™ is programmed "OFF".
- At the time of enrollment, patient is paced in the RV ≤ 60% of the time.
- Patient is medically stable.
Who cannot join
- Patient has evidence of complete AV block, such that ventricular pacing would be required as part of the patient's routine management.
- Patient is indicated for AF Suppression.
- Patient has persistent or chronic atrial fibrillation.
- Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
- Patient is currently participating in another device research study.
- Patient is younger than 18 years of age.
- Patient is pregnant.
- Patients life expectancy is less than 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduce Ventricular Pacing Using Ventricular Intrinsic Preference: VIP™ Study
The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with implanted SJM pacemakers will benefit by using VIP™ rather than only a programmed AV/PV delay.
- Conditions
- Bradycardia
- Being tested
- Intervention/treatment
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention/treatmentDevice
Device: VIP On
Device: VIP Off
| Study group | Role | What they receive |
|---|---|---|
| VIP On, Then VIP Off | Experimental | Participants first have VIP programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months. Receives: Device: Intervention/treatment |
| VIP Off, Then VIP On | Experimental | Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months. Receives: Device: Intervention/treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Intrinsic Ventricular Events
This outcome measured evaluated the difference in the percentage of intrinsic ventricular events between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Measured: 6 months after randomization
Secondary outcomes (7)
Incidence of Arrhythmias
This outcome measure evaluated the difference in the percentage of time a patient spent in atrial tachycardia/atrial fibrillation (arrhythmia burden) calculated by the device between VIP On and VIP Off.
Measured: 6 months after randomization
Percentage of Atrial Sensing to Ventricular Sensing (%PR)
This outcome measure evaluated the difference in the percentage of atrial sensing to ventricular sensing (%PR) detected by the device between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Measured: 6 months after randomization
Percentage of Atrial Sensing to Ventricular Pacing (%PV)
This outcome measure evaluated the difference in the percentage of Atrial Sensing to Ventricular Pacing (%PV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Measured: 6 months after randomization
Percentage of Atrial Pacing to Ventricular Sensing (%AR)
This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Sensing (%AR) between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Measured: 6 months after randomization
Percentage of Atrial Pacing to Ventricular Pacing (%AV)
This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Pacing (%AV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Measured: 6 months after randomization
Percentage of Patients Experiencing a Study-Related Adverse Event
This outcome measure evaluated the incidence of study-related adverse events between VIP On and VIP Off.
Measured: 6 months after randomization
Number of Auto Mode Switch Events
This outcome measure evaluated the difference in the number of auto mode switch events between VIP On and VIP Off.
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startFeb 2006
- Primary completionSep 2008
- Study completionSep 2008
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 BradycardiaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clay Cohorn, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311168
- Sponsor's protocol ID
- CRD343
- Status last verified
- Jul 2021
- First submitted
- 3 Apr 2006
- Last updated
- 12 Aug 2021
- 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 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduce Ventricular Pacing Using Ventricular Intrinsic Preference: VIP™ Study
- ClinicalTrials.gov ID
- NCT00311168
- Acronym / sponsor ID
- CRD343
- Conditions
- Bradycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 5 Apr 2006 (estimated)
- Results
- Posted 19 Jul 2021
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 evaluate the efficacy of the VIP™ feature (available in dual chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with implanted SJM pacemakers will benefit by using VIP™ rather than only a programmed AV/PV delay.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIP On, Then VIP Off | Experimental | Device: Intervention/treatmentParticipants first have VIP programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months. |
| VIP Off, Then VIP On | Experimental | Device: Intervention/treatmentParticipants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has been implanted with dual chamber SJM Victory® device with VIP™ for 1 month (± 2 weeks).
- At the time of pacemaker implant, VIP™ is programmed "OFF".
- At the time of enrollment, patient is paced in the RV ≤ 60% of the time.
- Patient is medically stable.
Key exclusion criteria (8 listed)
- Patient has evidence of complete AV block, such that ventricular pacing would be required as part of the patient's routine management.
- Patient is indicated for AF Suppression.
- Patient has persistent or chronic atrial fibrillation.
- Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
- Patient is currently participating in another device research study.
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 |
|---|---|---|
| Intervention/treatmentDevice: VIP On Device: VIP Off | Device | VIP Off, Then VIP On, VIP On, Then VIP Off |
Primary outcome
Percentage of Intrinsic Ventricular Events
Time frame: 6 months after randomization
This outcome measured evaluated the difference in the percentage of intrinsic ventricular events between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
7 secondary outcomes
Incidence of Arrhythmias
Time frame: 6 months after randomization
Percentage of Atrial Sensing to Ventricular Sensing (%PR)
Time frame: 6 months after randomization
Percentage of Atrial Sensing to Ventricular Pacing (%PV)
Time frame: 6 months after randomization
Percentage of Atrial Pacing to Ventricular Sensing (%AR)
Time frame: 6 months after randomization
Percentage of Atrial Pacing to Ventricular Pacing (%AV)
Time frame: 6 months after randomization
Percentage of Patients Experiencing a Study-Related Adverse Event
Time frame: 6 months after randomization
Number of Auto Mode Switch Events
Time frame: 6 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- 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.
Clay Cohorn study director
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention/treatment in people with Bradycardia, 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 4 inclusion and 8 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 12 Aug 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?
Yes. Results are posted in the registry (first posted 19 Jul 2021). 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?
Percentage of Intrinsic Ventricular Events (time frame: 6 months after randomization). 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 12 Aug 2021.