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The purpose of this study is to evaluate the possibility to program the shortest possible Post Ventricular Atrial Blanking Period (PVAB) and high sensitivity without getting inappropriate Mode Switch due to Far Field R-Wave sensing when using the new Tendril 1699T lead. Comparison with Tendril 1688T or 1388T with optimized Post Ventricular Atrial Blanking (PVAB).
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 the use of a new atrial screw in lead with ultra short tip-ring distance of 1.1 mm (Study Group) eliminates the need for individual adjustment of the postventricular atrial blanking period (PVAB) based on an additional test in the Control Group with standard leads.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1699T (Optisense) | Active Comparator | Implantation of the Optisense Lead 1699T, programming of the shortest possible postventricular atrial blanking period (PVAB) |
|
| Standard lead | Active Comparator | Implantation of a standard bipolar atrial pacing lead. Optimization of the postventricular atrial blanking period (PVAB) after implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pacemaker implantation | Device | St. Jude Medical Dual Chamber Pacemaker model Identity (ADx) DR, Victory DR, or newer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of inappropriate mode switch (documented by stored EGM's) using the atrial lead Tendril 1699T with short post ventricular atrial blanking period (PVAB) compared to standard atrial lead (Tentril 1388 or 1688) with optimised PVAB | 1 and 3 months post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of inappropriate mode switch in respect to lead position and ventricular stimulation frequency | 1 and 3 months post implantation | |
| Atrial Flutter in stored EGM's | 1 and 3 months post implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christof Kolb, MD | Deutsches Herzzentrum Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Coburg | Coburg | 96450 | Germany | |||
| Klinik Fränkische Schweiz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22745661 | Derived | Kolb C, Nolker G, Lennerz C, Jetter H, Semmler V, Purner K, Gutleben KJ, Reents T, Lang K, Lotze U; AVOID-FFS Investigators. Use of an atrial lead with very short tip-to-ring spacing avoids oversensing of far-field R-wave. PLoS One. 2012;7(6):e38277. doi: 10.1371/journal.pone.0038277. Epub 2012 Jun 22. |
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|
| 2:1 lock in of Atrial Flutter | 1 and 3 months post implantation |
| Ebermannstadt |
| 91320 |
| Germany |
| Kreisklinik Ebersberg | Ebersberg | 85560 | Germany |
| Krankenhaus Waltershausen-Friedrichroda | Friedrichroda | 99894 | Germany |
| Universitäres Herzzentrum Hamburg | Hamburg | 20246 | Germany |
| Klinikum Memmingen | Memmingen | 87700 | Germany |
| Deutsches Herzzentrum Muenchen | Munich | 80636 | Germany |
| Kardiologische Praxis Dres. med. Bödigheimer / Mühling / Prof. Dr. med. Silber | München | 80331 | Germany |
| Kreiskrankenhaus Ottweiler | Ottweiler | 66564 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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