A Phase 4 interventional study of pacemaker implantation in Atrial Fibrillation and Bradycardia, sponsored by Abbott Medical Devices. Completed at 10 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.
Sponsored by Abbott Medical Devices · Phase 4, Interventional, and Prevention
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.
3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's enrollment of 204 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Implantation of the Optisense Lead 1699T, programming of the shortest possible postventricular atrial blanking period (PVAB)
Device: pacemaker implantation
Implantation of a standard bipolar atrial pacing lead. Optimization of the postventricular atrial blanking period (PVAB) after implantation.
Device: pacemaker implantation
St. Jude Medical Dual Chamber Pacemaker model Identity (ADx) DR, Victory DR, or newer
Also known as: 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
Time frame: 1 and 3 months post implantation
Incidence of inappropriate mode switch in respect to lead position and ventricular stimulation frequency
Time frame: 1 and 3 months post implantation
Atrial Flutter in stored EGM's
Time frame: 1 and 3 months post implantation
2:1 lock in of Atrial Flutter
Time frame: 1 and 3 months post implantation
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Abbott Medical Devices