FFS – Far Field Sensing Test Study in Cardiac Dual Chamber Pacemakers

Overview

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.

Full Title of Study: “Far Field Sensing Test Study in Patients With Implanted Cardiac Dual Chamber Pacemakers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)

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

  • Device: Individualized Programming of PVAB
    • Performance of a test to detect far-field R-wave sensing
  • Device: Nominal PVAB
    • nominal pacemaker settings

Arms, Groups and Cohorts

  • Experimental: 1
    • Optimization of the postventricular atrial blanking period to avoid far-field R-wave sensing.
  • Experimental: 2
    • Programming of the nominal setting for the post-ventricular atrial blanking period (100 ms)

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of inappropriate mode switch due to far field R-wave sensing
    • Time Frame: 3 months

Secondary Measures

  • Incidence of inappropriate mode switch due to far field R-wave sensing in relation to the lead position
    • Time Frame: 3 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Deutsches Herzzentrum Muenchen
  • Overall Official(s)
    • Claus Schmitt, MD, Study Chair, Deutsches Herzzentrum Muenchen
    • Christof Kolb, MD, Principal Investigator, Deutsches Herzzentrum Muenchen

Citations Reporting on Results

Kolb C, Wille B, Maurer D, Schuchert A, Weber R, Schibgilla V, Klein N, Hümmer A, Schmitt C, Zrenner B; FFS-Test Study Group. Management of far-field R wave sensing for the avoidance of inappropriate mode switch in dual chamber pacemakers: results of the FFS-test study. J Cardiovasc Electrophysiol. 2006 Sep;17(9):992-7.

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