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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196144
First Posted: September 20, 2005
Last Update Posted: November 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Deutsches Herzzentrum Muenchen
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: November 26, 2007
Last Verified: November 2007

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