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

November 23, 2007 updated by: Deutsches Herzzentrum Muenchen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80636
        • Deutsches Herzzentrum Muenchen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Optimization of the postventricular atrial blanking period to avoid far-field R-wave sensing.
Device: Individualized Programming of PVAB
Performance of a test to detect far-field R-wave sensing
Experimental: 2
Programming of the nominal setting for the post-ventricular atrial blanking period (100 ms)
Device: Nominal PVAB
nominal pacemaker settings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of inappropriate mode switch due to far field R-wave sensing
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of inappropriate mode switch due to far field R-wave sensing in relation to the lead position
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

November 26, 2007

Last Update Submitted That Met QC Criteria

November 23, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. P00202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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