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

This study has been completed.
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00196144
First received: September 12, 2005
Last updated: November 23, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Device: Individualized Programming of PVAB
Device: Nominal PVAB
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Far Field Sensing Test Study in Patients With Implanted Cardiac Dual Chamber Pacemakers

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Incidence of inappropriate mode switch due to far field R-wave sensing [ Time Frame: 3 months ]

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

Enrollment: 207
Study Start Date: July 2002
Study Completion Date: April 2004
Arms Assigned Interventions
Experimental: 1
Optimization of the postventricular atrial blanking period to avoid far-field R-wave sensing.
Device: Individualized Programming of PVAB
Performance of a test to detect far-field R-wave sensing
Experimental: 2
Programming of the nominal setting for the post-ventricular atrial blanking period (100 ms)
Device: Nominal PVAB
nominal pacemaker settings

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196144

Locations
Germany
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Claus Schmitt, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Christof Kolb, MD Deutsches Herzzentrum Muenchen
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00196144     History of Changes
Other Study ID Numbers: GE IDE No. P00202
Study First Received: September 12, 2005
Last Updated: November 23, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014