BradycardiaPAFOSNCT01912326
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation
A study testing Pacemaker Implantation in people with Bradycardia and Atrial Fibrillation, run by Abbott Medical Devices at 1 site in Germany.
Trial summary
Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Bradycardia, Atrial Fibrillation
- What is being tested?
- Pacemaker Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2002to Apr 2008
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication for dual chamber pacemaker
- documented paroxysmal or persistent Atrial Fibrillation
- P-wave >1.0 mV in Sinus Rhythm or sufficient detection of AFib
- stable antyarrhythmic therapy
- age >= 19 years
- written informed consent
- implantation of a Identity DR 5370/5376 or later
- bipolar atrial lead
Who cannot join
- permanent AFib
- reversible etiology of AFib
- HYHA II or IV
- Coronary Artery disease with stable angina pectoris
- implanted ICD or planned implantation of a ICD
- cardiac surgery within the last 6 months or planned within 12 months
- live expectancy < 12 months
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming.
Hypothesis:
Dynamic atrial Overdrive (AF Suppression) reduces AT/AF Burden by 30% as compared to programming DDDR-(60) without AF Suppression when all other parameters are optimized.
Read the detailed description
Atrial Fibrillation is the most common Heart Rhythm Disorder requiring therapy.
- Conditions
- Bradycardia, Atrial Fibrillation
- Being tested
- Pacemaker Implantation
- Keywords
- pacemaker, atrial fibrillation
- Medical subject headings
- Bradycardia, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker ImplantationDevice
Also called Pacemaker St. Jude Medical Identity DR Model 5370 or 5376
Implantation of a dual chamber pacemaker
| Study group | Role | What they receive |
|---|---|---|
| AF Suppression On | Active comparator | AF Suppression Algorithm On, optimized AF Pacemaker Programming Receives: Device: Pacemaker Implantation |
| AF Suppression Off | Active comparator | AF Suppression programmed Off, Optimized Pacemaker Programming Receives: Device: Pacemaker Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of AT/AF Burden in the pacemaker diagnostics
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJul 2002
- Primary completionJan 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 249 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
- NCT01912326
- Sponsor's protocol ID
- B01- 408
- Acronym
- PAFOS
- Status last verified
- Oct 2024
- First submitted
- 26 Jul 2013
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation
- ClinicalTrials.gov ID
- NCT01912326
- Acronym / sponsor ID
- PAFOS / B01- 408
- Conditions
- Bradycardia, Atrial Fibrillation
- Keywords
- pacemaker, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 31 Jul 2013 (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.
Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming.
Hypothesis:
Dynamic atrial Overdrive (AF Suppression) reduces AT/AF Burden by 30% as compared to programming DDDR-(60) without AF Suppression when all other parameters are optimized.
Detailed description
Atrial Fibrillation is the most common Heart Rhythm Disorder requiring therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF Suppression On | Active comparator | Device: Pacemaker ImplantationAF Suppression Algorithm On, optimized AF Pacemaker Programming |
| AF Suppression Off | Active comparator | Device: Pacemaker ImplantationAF Suppression programmed Off, Optimized Pacemaker Programming |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- indication for dual chamber pacemaker
- documented paroxysmal or persistent Atrial Fibrillation
- P-wave >1.0 mV in Sinus Rhythm or sufficient detection of AFib
- stable antyarrhythmic therapy
- age >= 19 years
Key exclusion criteria (8 listed)
- permanent AFib
- reversible etiology of AFib
- HYHA II or IV
- Coronary Artery disease with stable angina pectoris
- implanted ICD or planned implantation of a ICD
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 |
|---|---|---|
| Pacemaker ImplantationAlso: Pacemaker St. Jude Medical Identity DR Model 5370 or 5376Implantation of a dual chamber pacemaker | Device | AF Suppression Off, AF Suppression On |
Primary outcome
Reduction of AT/AF Burden in the pacemaker diagnostics
Time frame: 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 8 Oct 2024.
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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 Pacemaker Implantation in people with Bradycardia and Atrial Fibrillation, run by Abbott Medical Devices at 1 site in Germany.
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 8 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 8 Oct 2024. 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 Germany. 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?
Reduction of AT/AF Burden in the pacemaker diagnostics (time frame: 12 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 8 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.