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

Sponsor:	Deutsches Herzzentrum Muenchen
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00196144

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 IV

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

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:

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.

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 February 09, 2012