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Completed

NCT Number: NCT00196144

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized Programming of PVAB

Device

Performance of a test to detect far-field R-wave sensing

Nominal PVAB

Device

nominal pacemaker settings

Primary outcomes

  1. Incidence of inappropriate mode switch due to far field R-wave sensing

    Time frame: 3 months

Secondary outcomes

  1. Incidence of inappropriate mode switch due to far field R-wave sensing in relation to the lead position

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Official study title

Far Field Sensing Test Study in Patients With Implanted Cardiac Dual Chamber Pacemakers

Important dates

Study start
2002
Study completion
2004
First posted
Sep 20, 2005
Registry last updated
Nov 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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