Sick Sinus SyndromeOSATNCT01074749
Optimal Sensing in Atrial Tachyarrhythmia's Study
A study testing Accent Pacemaker in people with Sick Sinus Syndrome and Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 1 site in Netherlands.
Trial summary
The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT), and the rejection of far field sensing of the far field R-wave (FFRW). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sick Sinus Syndrome, Paroxysmal Atrial Fibrillation
- What is being tested?
- Accent Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2010to Jul 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 class I or II pacing indications for Sick Sinus Syndrome with suspected paroxysmal atrial tachyarrhythmias over the last 6 months
- Signed informed consent
- Age >18 yrs
Who cannot join
- Severe valvular heart disease (echocardiogram less than 6 months old)
- Angina Pectoris class ≥ III
- Congestive heart failure - NYHA class ≥ III
- Left Ventricular Ejection Fraction < 35% (less than 6 months old)
- Hypertrophic Cardiomyopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OSAT: Optimal Sensing in Atrial Tachyarrhythmia's Study
The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT), and the rejection of far field sensing of the far field R-wave (FFRW).
Read the detailed description
The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal AF and AT and the rejection of far field sensing of the far field R-wave (FFRW). The study aims to evaluate the accuracy of the detection of atrial tachyarrhythmias (ATAs). An improved detection can potentially increase the accuracy of clinical treatment decisions, based on device derived data.
- Being tested
- Accent Pacemaker
- Keywords
- AF, Automatic Mode Switch, FFRW, paroxysmal AF
- Medical subject headings
- Sick Sinus Syndrome, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accent PacemakerDevice
Also called Accent DR RF 2212 Pacemaker, OptiSense 1999 atrial lead
Implantation of pacemaker
| Study group | Role | What they receive |
|---|---|---|
| Optisense lead | Active comparator | Patients with an Accent pacemaker and an OptiSense atrial lead Receives: Device: Accent Pacemaker |
| Tendril lead | Active comparator | Patients with an Accent pacemaker and a Tendril atrial lead Receives: Device: Accent Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of undersensing of paroxysmal AF and AT from Holter recording.
Measured: 1-3 months
Secondary outcomes (1)
Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2014
- Study completionJul 2014
Why it stopped: Interim analysis indicated that endpoints can not be analysed with current dataset.
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 Sick Sinus SyndromeStudies 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Willem De Voogt, MD PhD, Principal investigator, St Lucas Andreas Hospital Amsterdam, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074749
- Sponsor's protocol ID
- CR-09-058-ND-LV
- Acronym
- OSAT
- Status last verified
- Feb 2019
- First submitted
- 22 Feb 2010
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pakarinen S, Lehto M, Ruiter J, de Voogt WG. Enhanced detection of atrial tachyarrhythmias with pacing devices by using more accurate atrial sensing. J Interv Card Electrophysiol. 2022 Apr;63(3):601-609. doi: 10.1007/s10840-021-01066-z. Epub 2021 Oct 1.
PubMed 34599455
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
- OSAT: Optimal Sensing in Atrial Tachyarrhythmia's Study
- ClinicalTrials.gov ID
- NCT01074749
- Acronym / sponsor ID
- OSAT / CR-09-058-ND-LV
- Keywords
- AF, Automatic Mode Switch, FFRW, paroxysmal AF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis indicated that endpoints can not be analysed with current dataset.
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Feb 2010 (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 aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT), and the rejection of far field sensing of the far field R-wave (FFRW).
Detailed description
The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal AF and AT and the rejection of far field sensing of the far field R-wave (FFRW). The study aims to evaluate the accuracy of the detection of atrial tachyarrhythmias (ATAs). An improved detection can potentially increase the accuracy of clinical treatment decisions, based on device derived data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optisense lead | Active comparator | Device: Accent PacemakerPatients with an Accent pacemaker and an OptiSense atrial lead |
| Tendril lead | Active comparator | Device: Accent PacemakerPatients with an Accent pacemaker and a Tendril atrial lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with class I or II pacing indications for Sick Sinus Syndrome with suspected paroxysmal atrial tachyarrhythmias over the last 6 months
- Signed informed consent
- Age >18 yrs
Key exclusion criteria (5 listed)
- Severe valvular heart disease (echocardiogram less than 6 months old)
- Angina Pectoris class ≥ III
- Congestive heart failure - NYHA class ≥ III
- Left Ventricular Ejection Fraction < 35% (less than 6 months old)
- Hypertrophic Cardiomyopathy
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 |
|---|---|---|
| Accent PacemakerAlso: Accent DR RF 2212 Pacemaker, OptiSense 1999 atrial leadImplantation of pacemaker | Device | Optisense lead, Tendril lead |
Primary outcome
Number of undersensing of paroxysmal AF and AT from Holter recording.
Time frame: 1-3 months
1 secondary outcome
Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm.
Time frame: 1-3 months
Results and safety
The study was stopped early (reason given: Interim analysis indicated that endpoints can not be analysed with current dataset.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Derived from this study: PubMed 34599455Pakarinen S, Lehto M, Ruiter J, de Voogt WG. Enhanced detection of atrial tachyarrhythmias with pacing devices by using more accurate atrial sensing. J Interv Card Electrophysiol. 2022 Apr;63(3):601-609. doi: 10.1007/s10840-021-01066-z. Epub 2021 Oct 1.
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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.
Willem De Voogt, MD PhD principal investigator
St Lucas Andreas Hospital Amsterdam, Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accent Pacemaker in people with Sick Sinus Syndrome and Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 1 site in Netherlands.
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 5 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: stopped early, 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 Netherlands. 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 was stopped early (reason given: Interim analysis indicated that endpoints can not be analysed with current dataset.). Results are not available in the source record.
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?
Number of undersensing of paroxysmal AF and AT from Holter recording. (time frame: 1-3 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 NCT01074749, 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.