Avoid FFS - Use of the Atrial Pacemaker Lead 1699 With Very Short Tip Ring Spacing to Avoid Far Field Sensing (Avoid FFS)

Avoid FFS - Use of the Atrial Pacemaker Lead 1699 With Very Short Tip Ring Spacing to Avoid Far Field Sensing

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.

Implantation of the Optisense Lead 1699T, programming of the shortest possible postventricular atrial blanking period (PVAB)

Implantation of a standard bipolar atrial pacing lead. Optimization of the postventricular atrial blanking period (PVAB) after implantation.

Active Arm: 1699T Tendril Optisense lead, Standard lead: 1688T Tendril SDX, 1788T Tendril ST, 1888T Tendril ST OPTIM

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

Incidence of inappropriate mode switch in respect to lead position and ventricular stimulation frequency

Inclusion Criteria: Indication for dual chamber pacing Implantation of an Identity (ADX) DR or Victory or later pacemaker (St. Jude Medical) Bipolar atrial pacing electrode Age >= 18 years Exclusion Criteria: Persistent / permanent Atrial Arrhythmia Pacemaker Revision Pregnancy Participation in another Study involving active implantable medical devices Unable to complete follow up Missing patient informed consent Cardiac surgery or myocardial infarction within the last 4 weeks Planned cardiac surgery within 3 months after enrollment

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.