ArrhythmiaNCT00366158
EVITA: Evaluation of VIP Feature in Pacemaker Patients
A study testing Device: St. Jude Medical Victory dual-chamber pacemaker and Ventricular Intrinsic Preference in people with Arrhythmia, run by Abbott Medical Devices at 2 sites in 2 countries.
Trial summary
The primary efficacy objective of this clinical investigation is to demonstrate that the Ventricular Intrinsic Preference (VIP™) feature allows to reduce the medium- and long-term incidence of unnecessary ventricular pacing in patients with intact AV conduction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Device: St. Jude Medical Victory dual-chamber pacemaker and Ventricular Intrinsic Preference
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2006to Sep 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has an indication for implantation of a dual-chamber pacemaker;
- Patient is implanted or scheduled to be implanted with a St Jude Medical Victory pacemaker, or newer device with the same study relevant feature.
Who cannot join
- Patient has persistent or permanent AF/AFl;
- Patient has permanent AV Block;
- Patient has a pacemaker replacement;
- Patient is in NYHA class IV;
- Patient is unable to attend the follow-up visits;
- Patient is pregnant;
- Patient is less than 18 years of age
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The primary efficacy objective of this clinical investigation is to demonstrate that the Ventricular Intrinsic Preference (VIP™) feature allows to reduce the medium- and long-term incidence of unnecessary ventricular pacing in patients with intact AV conduction.
- Conditions
- Arrhythmia
- Being tested
- Device: St. Jude Medical Victory dual-chamber pacemaker, Ventricular Intrinsic Preference
- Keywords
- Patients with intact AV conduction
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: St. Jude Medical Victory dual-chamber pacemakerDevice
Pacemaker implant
Ventricular Intrinsic PreferenceDevice
Programming of pacemaker
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ventricular Instrinsic Preference (VIP) turned ON Receives: Device: Device: St. Jude Medical Victory dual-chamber pacemaker; Device: Ventricular Intrinsic Preference |
| 2 | Active comparator | Ventricular Instrinsic Preference (VIP) turned OFF Receives: Device: Device: St. Jude Medical Victory dual-chamber pacemaker; Device: Ventricular Intrinsic Preference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of ventricular pacing
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJun 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alexander Bauer, MD, Study chair, Universitätskliniken Heidelberg, Heidelberg, 69115, GermanyCharles Kennergren, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366158
- Sponsor's protocol ID
- CR06001LV
- Status last verified
- Feb 2019
- First submitted
- 18 Aug 2006
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Bauer A, Vermeulen J, Toivonen L, Voitk J, Barr C, Peytchev P. Minimizing right ventricular pacing in pacemaker patients with intact and compromised atrioventricular conduction : Results from the EVITA Trial. Herzschrittmacherther Elektrophysiol. 2015 Dec;26(4):359-66. doi: 10.1007/s00399-015-0394-2. Epub 2015 Aug 28.
PubMed 26315154
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
- EVITA: Evaluation of VIP Feature in Pacemaker Patients
- ClinicalTrials.gov ID
- NCT00366158
- Acronym / sponsor ID
- CR06001LV
- Conditions
- Arrhythmia
- Keywords
- Patients with intact AV conduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Aug 2006 (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 primary efficacy objective of this clinical investigation is to demonstrate that the Ventricular Intrinsic Preference (VIP™) feature allows to reduce the medium- and long-term incidence of unnecessary ventricular pacing in patients with intact AV conduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Device: St. Jude Medical Victory dual-chamber pacemaker, Device: Ventricular Intrinsic PreferenceVentricular Instrinsic Preference (VIP) turned ON |
| 2 | Active comparator | Device: Device: St. Jude Medical Victory dual-chamber pacemaker, Device: Ventricular Intrinsic PreferenceVentricular Instrinsic Preference (VIP) turned OFF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has an indication for implantation of a dual-chamber pacemaker;
- Patient is implanted or scheduled to be implanted with a St Jude Medical Victory pacemaker, or newer device with the same study relevant feature.
Key exclusion criteria (7 listed)
- Patient has persistent or permanent AF/AFl;
- Patient has permanent AV Block;
- Patient has a pacemaker replacement;
- Patient is in NYHA class IV;
- Patient is unable to attend the follow-up visits;
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 |
|---|---|---|
| Device: St. Jude Medical Victory dual-chamber pacemakerPacemaker implant | Device | 1, 2 |
| Ventricular Intrinsic PreferenceProgramming of pacemaker | Device | 1, 2 |
Primary outcome
Percentage of ventricular pacing
Time frame: 6 and 12 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.
- Derived from this study: PubMed 26315154Bauer A, Vermeulen J, Toivonen L, Voitk J, Barr C, Peytchev P. Minimizing right ventricular pacing in pacemaker patients with intact and compromised atrioventricular conduction : Results from the EVITA Trial. Herzschrittmacherther Elektrophysiol. 2015 Dec;26(4):359-66. doi: 10.1007/s00399-015-0394-2. Epub 2015 Aug 28.
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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.
Alexander Bauer, MD study chair
Universitätskliniken Heidelberg, Heidelberg, 69115, Germany
Charles Kennergren, MD principal investigator
Sahlgrenska University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: St. Jude Medical Victory dual-chamber pacemaker and Ventricular Intrinsic Preference in people with Arrhythmia, run by Abbott Medical Devices at 2 sites in 2 countries.
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 7 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 2 sites in Germany, Sweden. 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?
Percentage of ventricular pacing (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00366158, which also lists 1 linked publication.
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.