Trials / Completed
CompletedNCT00196144
FFS - Far Field Sensing Test Study in Cardiac Dual Chamber Pacemakers
Far Field Sensing Test Study in Patients With Implanted Cardiac Dual Chamber Pacemakers
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 207 (actual)
- Sponsor
- Deutsches Herzzentrum Muenchen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Individualized Programming of PVAB | Performance of a test to detect far-field R-wave sensing |
| DEVICE | Nominal PVAB | nominal pacemaker settings |
Timeline
- Start date
- 2002-07-01
- Completion
- 2004-04-01
- First posted
- 2005-09-20
- Last updated
- 2007-11-26
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00196144. Inclusion in this directory is not an endorsement.