NCT00196144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jul 2002

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

November 26, 2007

Status Verified

November 1, 2007

First QC Date

September 12, 2005

Last Update Submit

November 23, 2007

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (1)

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

    3 months

Study Arms (2)

1

EXPERIMENTAL

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

Device: Individualized Programming of PVAB

2

EXPERIMENTAL

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

Device: Nominal PVAB

Interventions

Individualized Programming of PVABDEVICE

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

1
Nominal PVABDEVICE

nominal pacemaker settings

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for dual chamber pacing
  • Implantation of an Identity DR pacemaker (St. Jude Medical)
  • Bipolar atrial pacing electrode

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Related Publications (1)

  • 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.

    PMID: 16948743RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Claus Schmitt, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

  • Christof Kolb, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

July 1, 2002

Study Completion

April 1, 2004

Last Updated

November 26, 2007

Record last verified: 2007-11

Locations

DE(1)