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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Optimization of the postventricular atrial blanking period to avoid far-field R-wave sensing. |
|
| 2 | Experimental | Programming of the nominal setting for the post-ventricular atrial blanking period (100 ms) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized Programming of PVAB | Device | Performance of a test to detect far-field R-wave sensing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of inappropriate mode switch due to far field R-wave sensing | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of inappropriate mode switch due to far field R-wave sensing in relation to the lead position | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claus Schmitt, MD | Deutsches Herzzentrum Muenchen | Study Chair |
| Christof Kolb, MD | Deutsches Herzzentrum Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum Muenchen | Munich | 80636 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16948743 | Result | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Nominal PVAB |
| Device |
nominal pacemaker settings |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |