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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Individualized Programming of PVAB

Nominal PVAB

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Deutsches Herzzentrum Muenchen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00196144

First Posted

September 12, 2005

Last Updated

November 23, 2007

Sponsor

Deutsches Herzzentrum Muenchen

1. Study Identification

Unique Protocol Identification Number

NCT00196144

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

July 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

207 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Individualized Programming of PVAB

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Nominal PVAB

Intervention Description

nominal pacemaker settings

Primary Outcome Measure Information:

Title

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claus Schmitt, MD

Organizational Affiliation

Deutsches Herzzentrum Muenchen

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Christof Kolb, MD

Organizational Affiliation

Deutsches Herzzentrum Muenchen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Deutsches Herzzentrum Muenchen

City

Munich

ZIP/Postal Code

80636

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

16948743

Citation

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.

Results Reference

result

Learn more about this trial

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

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