Clinical trial NCT00512915: Avoid FFS - Use of the Atrial Pacemaker Lead 1699 With Very Short Tip Ring Spacing to Avoid Far Field Sensing
Official title: Atriale Vorhofsonde 1699 Mit Sehr Kurzem Bipolabstand Zur Vermeidung Von Far Field Sensing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Bradycardia
Keywords: Farfield Sensing
Pacing lead
Postventricular atrial blanking
Bradycardia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-08-08
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 and 3 months post implantation
Secondary outcomes:
measure: Incidence of inappropriate mode switch in respect to lead position and ventricular stimulation frequency
timeFrame: 1 and 3 months post implantation
measure: Atrial Flutter in stored EGM's
timeFrame: 1 and 3 months post implantation
measure: 2:1 lock in of Atrial Flutter
timeFrame: 1 and 3 months post implantation
Other outcomes:
Locations:
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Ebermannstadt
country: Germany
facility: Klinik Fränkische Schweiz
city: Ebersberg
country: Germany
facility: Kreisklinik Ebersberg
city: Friedrichroda
country: Germany
facility: Krankenhaus Waltershausen-Friedrichroda
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Memmingen
country: Germany
facility: Klinikum Memmingen
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: München
country: Germany
facility: Kardiologische Praxis Dres. med. Bödigheimer / Mühling / Prof. Dr. med. Silber
city: Ottweiler
country: Germany
facility: Kreiskrankenhaus Ottweiler
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Christof Kolb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.