Atrial Fibrillation
Conditions
Brief summary
The purpose of this study is to evaluate the effect of individual adjustment of the postventricular atrial blanking period in avoiding inappropriate mode switch of dual chamber pacemakers.
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 individual adjustment of the postventricular atrial blanking period (PVAB) based on an additional test is effective in avoiding inappropriate mode switch due to FFS when compared to standard programming of the PVAB
Interventions
DEVICEIndividualized Programming of PVAB
Performance of a test to detect far-field R-wave sensing
DEVICENominal PVAB
nominal pacemaker settings
Sponsors
Deutsches Herzzentrum Muenchen
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 DR pacemaker (St. Jude Medical) * Bipolar atrial pacing electrode
Exclusion criteria
* Heart failure NYHA III and IV * Unstable angina pectoris * Indication for the implantation of an ICD * Cardiac surgery within previous 6 months * Cardiac surgery planed for the next 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of inappropriate mode switch due to far field R-wave sensing | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of inappropriate mode switch due to far field R-wave sensing in relation to the lead position | 3 months |
Countries
Germany
Outcome results
None listed