Atrial FibrillationPhase 4NCT00196144
FFS - Far Field Sensing Test Study in Cardiac Dual Chamber Pacemakers
A Phase 4 study testing Individualized Programming of PVAB and Nominal PVAB in people with Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the effect of individual adjustment of the postventricular atrial blanking period in avoiding inappropriate mode switch of dual chamber pacemakers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Individualized Programming of PVAB and Nominal PVAB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2002to Apr 2004
- Phase
- Phase 4
- 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
- Indication for dual chamber pacing
- Implantation of an Identity DR pacemaker (St. Jude Medical)
- Bipolar atrial pacing electrode
Who cannot join
- Heart failure NYHA III and IV
- Unstable angina pectoris
- Indication for the implantation of an ICD
- Cardiac surgery within previous 6 months
- Cardiac surgery planed for the next 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Far Field Sensing Test Study in Patients With Implanted Cardiac Dual Chamber Pacemakers
The purpose of this study is to evaluate the effect of individual adjustment of the postventricular atrial blanking period in avoiding inappropriate mode switch of dual chamber pacemakers.
Read the detailed description
Far-field R-wave sensing (FFS) in the atrial channel of dual chamber pacemakers is a relevant source for inappropriate mode switch from the DDD mode to the DDI or VDI mode. Inappropriate loss of atrioventricular synchrony due to false positive mode switch is hemodynamically disadvantageous, may induce atrial tachyarrhythmias, can lead to pacemaker syndrome, and impairs the reliability of pacemaker Holter data. The aim of the study is to determine whether individual adjustment of the postventricular atrial blanking period (PVAB) based on an additional test is effective in avoiding inappropriate mode switch due to FFS when compared to standard programming of the PVAB
- Conditions
- Atrial Fibrillation
- Being tested
- Individualized Programming of PVAB, Nominal PVAB
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Programming of PVABDevice
Performance of a test to detect far-field R-wave sensing
Nominal PVABDevice
nominal pacemaker settings
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Optimization of the postventricular atrial blanking period to avoid far-field R-wave sensing. Receives: Device: Individualized Programming of PVAB |
| 2 | Experimental | Programming of the nominal setting for the post-ventricular atrial blanking period (100 ms) Receives: Device: Nominal PVAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of inappropriate mode switch due to far field R-wave sensing
Measured: 3 months
Secondary outcomes (1)
Incidence of inappropriate mode switch due to far field R-wave sensing in relation to the lead position
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2002
- Study completionApr 2004
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 Atrial FibrillationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Investigators
- Claus Schmitt, MD, Study chair, Deutsches Herzzentrum MuenchenChristof Kolb, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196144
- Sponsor's protocol ID
- GE IDE No. P00202
- Status last verified
- Nov 2007
- First submitted
- 12 Sep 2005
- Last updated
- 26 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kolb C, Wille B, Maurer D, Schuchert A, Weber R, Schibgilla V, Klein N, Hummer A, Schmitt C, Zrenner B; FFS-Test Study Group. Management of far-field R wave sensing for the avoidance of inappropriate mode switch in dual chamber pacemakers: results of the FFS-test study. J Cardiovasc Electrophysiol. 2006 Sep;17(9):992-7. doi: 10.1111/j.1540-8167.2006.00545.x.
PubMed 16948743
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Far Field Sensing Test Study in Patients With Implanted Cardiac Dual Chamber Pacemakers
- ClinicalTrials.gov ID
- NCT00196144
- Acronym / sponsor ID
- GE IDE No. P00202
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Jul 2002
- Study completion
- Apr 2004 (actual)
- First posted
- 20 Sep 2005 (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 purpose of this study is to evaluate the effect of individual adjustment of the postventricular atrial blanking period in avoiding inappropriate mode switch of dual chamber pacemakers.
Detailed description
Far-field R-wave sensing (FFS) in the atrial channel of dual chamber pacemakers is a relevant source for inappropriate mode switch from the DDD mode to the DDI or VDI mode. Inappropriate loss of atrioventricular synchrony due to false positive mode switch is hemodynamically disadvantageous, may induce atrial tachyarrhythmias, can lead to pacemaker syndrome, and impairs the reliability of pacemaker Holter data. The aim of the study is to determine whether individual adjustment of the postventricular atrial blanking period (PVAB) based on an additional test is effective in avoiding inappropriate mode switch due to FFS when compared to standard programming of the PVAB
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Individualized Programming of PVABOptimization of the postventricular atrial blanking period to avoid far-field R-wave sensing. |
| 2 | Experimental | Device: Nominal PVABProgramming of the nominal setting for the post-ventricular atrial blanking period (100 ms) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for dual chamber pacing
- Implantation of an Identity DR pacemaker (St. Jude Medical)
- Bipolar atrial pacing electrode
Key exclusion criteria (5 listed)
- Heart failure NYHA III and IV
- Unstable angina pectoris
- Indication for the implantation of an ICD
- Cardiac surgery within previous 6 months
- Cardiac surgery planed for the next 3 months
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 |
|---|---|---|
| Individualized Programming of PVABPerformance of a test to detect far-field R-wave sensing | Device | 1 |
| Nominal PVABnominal pacemaker settings | Device | 2 |
Primary outcome
Incidence of inappropriate mode switch due to far field R-wave sensing
Time frame: 3 months
1 secondary outcome
Incidence of inappropriate mode switch due to far field R-wave sensing in relation to the lead position
Time frame: 3 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 26 Nov 2007.
- Results publication: PubMed 16948743Kolb C, Wille B, Maurer D, Schuchert A, Weber R, Schibgilla V, Klein N, Hummer A, Schmitt C, Zrenner B; FFS-Test Study Group. Management of far-field R wave sensing for the avoidance of inappropriate mode switch in dual chamber pacemakers: results of the FFS-test study. J Cardiovasc Electrophysiol. 2006 Sep;17(9):992-7. doi: 10.1111/j.1540-8167.2006.00545.x.
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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.
Claus Schmitt, MD study chair
Deutsches Herzzentrum Muenchen
Christof Kolb, MD principal investigator
Deutsches Herzzentrum Muenchen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Individualized Programming of PVAB and Nominal PVAB in people with Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen 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 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: finished, as of the sponsor's last update on 26 Nov 2007. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of inappropriate mode switch due to far field R-wave sensing (time frame: 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 NCT00196144, 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 26 Nov 2007.