Sinus Node DiseaseOPTIMISTNCT02485093
To Pace or Not to Pace in Sinus Node Disease
A study testing Septal ventricular pacing and VIP in people with Sinus Node Disease, run by Abbott Medical Devices at 1 site in France.
Trial summary
Optimal pacing strategy for patients with SND is still unknown, although several publications in the past years demonstrated a deleterious effect of ventricular pacing. However, pacing has always been apical in these trials, and to which extent this absence of pacing is beneficial for patients with very long PR… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Node Disease
- What is being tested?
- Septal ventricular pacing and VIP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Oct 2014
- 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
- Patients with sinus node disease
Who cannot join
- Complete or high degree AV block
- Permanent atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ventricular Septal Pacing With Optimized Atrioventricular (AV) Delay to no Pacing in Sinus Node Disease (SND) Patients.
Optimal pacing strategy for patients with SND is still unknown, although several publications in the past years demonstrated a deleterious effect of ventricular pacing. However, pacing has always been apical in these trials, and to which extent this absence of pacing is beneficial for patients with very long PR intervals is still to be found.
The aim of this study is to compare ventricular septal pacing to no pacing in patients with SND.
- Conditions
- Sinus Node Disease
- Being tested
- Septal ventricular pacing, VIP
- Medical subject headings
- Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Septal ventricular pacingDevice
Ventricular pacing must be at least 90%, from the septum and with optimized AV delay
VIPDevice
Ventricular pacing must be less than 10%.
| Study group | Role | What they receive |
|---|---|---|
| No pacing | Active comparator | Ventricular intrinsic conduction enhanced Receives: Device: VIP |
| Pacing | Experimental | Septal ventricular pacing with optimized AV delay Receives: Device: Septal ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Endsystolic Diameter (LVED)
Measured: 18 months
Secondary outcomes (2)
AF incidence
Measured: 18 months
Hospitalizations
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJun 2009
- Primary completionJul 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Node DiseaseStudies 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
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485093
- Sponsor's protocol ID
- 2008-A01266-49
- Acronym
- OPTIMIST
- Status last verified
- Feb 2019
- First submitted
- 26 Jul 2013
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- 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
- Comparison of Ventricular Septal Pacing With Optimized Atrioventricular (AV) Delay to no Pacing in Sinus Node Disease (SND) Patients.
- ClinicalTrials.gov ID
- NCT02485093
- Acronym / sponsor ID
- OPTIMIST / 2008-A01266-49
- Conditions
- Sinus Node Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Jun 2015 (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.
Optimal pacing strategy for patients with SND is still unknown, although several publications in the past years demonstrated a deleterious effect of ventricular pacing. However, pacing has always been apical in these trials, and to which extent this absence of pacing is beneficial for patients with very long PR intervals is still to be found.
The aim of this study is to compare ventricular septal pacing to no pacing in patients with SND.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No pacing | Active comparator | Device: VIPVentricular intrinsic conduction enhanced |
| Pacing | Experimental | Device: Septal ventricular pacingSeptal ventricular pacing with optimized AV delay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with sinus node disease
Key exclusion criteria (2 listed)
- Complete or high degree AV block
- Permanent atrial fibrillation
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 |
|---|---|---|
| Septal ventricular pacingVentricular pacing must be at least 90%, from the septum and with optimized AV delay | Device | Pacing |
| VIPVentricular pacing must be less than 10%. | Device | No pacing |
Primary outcome
Left Ventricular Endsystolic Diameter (LVED)
Time frame: 18 months
2 secondary outcomes
AF incidence
Time frame: 18 months
Hospitalizations
Time frame: 18 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Septal ventricular pacing and VIP in people with Sinus Node Disease, run by Abbott Medical Devices at 1 site in France.
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 2 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 France. 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?
Left Ventricular Endsystolic Diameter (LVED) (time frame: 18 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.