Atrial Fibrillation, Bradycardia
Conditions
Keywords
Farfield Sensing, Pacing lead, Postventricular atrial blanking, Bradycardia
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.
Interventions
DEVICEpacemaker implantation
St. Jude Medical Dual Chamber Pacemaker model Identity (ADx) DR, Victory DR, or newer
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 2:1 lock in of Atrial Flutter | 1 and 3 months post implantation |
Countries
Germany
Outcome results
None listed