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

German Heart Center Munich

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Device: Individualized Programming of PVAB; Device: Nominal PVAB

Study type: Interventional

Funder types: Other

Identifiers

NCT00196144

GE IDE No. P00202

Details and patient eligibility

About

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.

Full 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

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

207 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Device: Individualized Programming of PVAB

2

Experimental group

Description:

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

Treatment:

Device: Nominal PVAB