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

NCT ID: NCT00196144

Last Updated: 2007-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2004-04-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Optimization of the postventricular atrial blanking period to avoid far-field R-wave sensing.

Group Type EXPERIMENTAL

Individualized Programming of PVAB

Intervention Type DEVICE

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

2

Programming of the nominal setting for the post-ventricular atrial blanking period (100 ms)

Group Type EXPERIMENTAL

Nominal PVAB

Intervention Type DEVICE

nominal pacemaker settings

Interventions

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Individualized Programming of PVAB

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

Intervention Type DEVICE

Nominal PVAB

nominal pacemaker settings

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Principal Investigators

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Claus Schmitt, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Muenchen

Christof Kolb, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

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Deutsches Herzzentrum Muenchen

Munich, , Germany

Site Status

Countries

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Germany

References

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Kolb C, Wille B, Maurer D, Schuchert A, Weber R, Schibgilla V, Klein N, Hummer 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. doi: 10.1111/j.1540-8167.2006.00545.x.

Reference Type RESULT
PMID: 16948743 (View on PubMed)

Other Identifiers

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GE IDE No. P00202

Identifier Type: -

Identifier Source: org_study_id