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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196144
• Other study ID #: GE IDE No. P00202
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: November 23, 2007
• Start date: July 2002
• Est. completion date: April 2004

Study information

• Verified date: November 2007
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Individualized Programming of PVAB
Performance of a test to detect far-field R-wave sensing
• Nominal PVAB
nominal pacemaker settings

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of inappropriate mode switch due to far field R-wave sensing		3 months
Secondary	Incidence of inappropriate mode switch due to far field R-wave sensing in relation to the lead position		3 months