Avoid FFS - Use of the Atrial Pacemaker Lead 1699 With Very Short Tip Ring Spacing to Avoid Far Field Sensing (Avoid FFS)

February 1, 2019 updated by: Abbott Medical Devices

Atriale Vorhofsonde 1699 Mit Sehr Kurzem Bipolabstand Zur Vermeidung Von Far Field Sensing

The purpose of this study is to evaluate the possibility to program the shortest possible Post Ventricular Atrial Blanking Period (PVAB) and high sensitivity without getting inappropriate Mode Switch due to Far Field R-Wave sensing when using the new Tendril 1699T lead. Comparison with Tendril 1688T or 1388T with optimized Post Ventricular Atrial Blanking (PVAB).

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 the use of a new atrial screw in lead with ultra short tip-ring distance of 1.1 mm (Study Group) eliminates the need for individual adjustment of the postventricular atrial blanking period (PVAB) based on an additional test in the Control Group with standard leads.

Study Type

Interventional

Enrollment (Actual)

204

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
      • Coburg, Germany, 96450
        • Klinikum Coburg
      • Ebermannstadt, Germany, 91320
        • Klinik Fränkische Schweiz
      • Ebersberg, Germany, 85560
        • Kreisklinik Ebersberg
      • Friedrichroda, Germany, 99894
        • Krankenhaus Waltershausen-Friedrichroda
      • Hamburg, Germany, 20246
        • Universitäres Herzzentrum Hamburg
      • Memmingen, Germany, 87700
        • Klinikum Memmingen
      • Munich, Germany, 80636
        • Deutsches Herzzentrum Muenchen
      • München, Germany, 80331
        • Kardiologische Praxis Dres. med. Bödigheimer / Mühling / Prof. Dr. med. Silber
      • Ottweiler, Germany, 66564
        • Kreiskrankenhaus Ottweiler
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm

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 (ADX) DR or Victory or later pacemaker (St. Jude Medical)
  • Bipolar atrial pacing electrode
  • Age >= 18 years

Exclusion Criteria:

  • Persistent / permanent Atrial Arrhythmia
  • Pacemaker Revision
  • Pregnancy
  • Participation in another Study involving active implantable medical devices
  • Unable to complete follow up
  • Missing patient informed consent
  • Cardiac surgery or myocardial infarction within the last 4 weeks
  • Planned cardiac surgery within 3 months after enrollment

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1699T (Optisense)
Implantation of the Optisense Lead 1699T, programming of the shortest possible postventricular atrial blanking period (PVAB)
Device: pacemaker implantation
St. Jude Medical Dual Chamber Pacemaker model Identity (ADx) DR, Victory DR, or newer
Other Names:
  • Active Arm: 1699T Tendril Optisense lead
  • Standard lead: 1688T Tendril SDX, 1788T Tendril ST, 1888T Tendril ST OPTIM
ACTIVE_COMPARATOR: Standard lead
Implantation of a standard bipolar atrial pacing lead. Optimization of the postventricular atrial blanking period (PVAB) after implantation.
Device: pacemaker implantation
St. Jude Medical Dual Chamber Pacemaker model Identity (ADx) DR, Victory DR, or newer
Other Names:
  • Active Arm: 1699T Tendril Optisense lead
  • Standard lead: 1688T Tendril SDX, 1788T Tendril ST, 1888T Tendril ST OPTIM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of inappropriate mode switch (documented by stored EGM's) using the atrial lead Tendril 1699T with short post ventricular atrial blanking period (PVAB) compared to standard atrial lead (Tentril 1388 or 1688) with optimised PVAB
Time Frame: 1 and 3 months post implantation
1 and 3 months post implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of inappropriate mode switch in respect to lead position and ventricular stimulation frequency
Time Frame: 1 and 3 months post implantation
1 and 3 months post implantation
Atrial Flutter in stored EGM's
Time Frame: 1 and 3 months post implantation
1 and 3 months post implantation
2:1 lock in of Atrial Flutter
Time Frame: 1 and 3 months post implantation
1 and 3 months post implantation

Collaborators and Investigators

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

Sponsor

Abbott Medical Devices

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

December 1, 2006

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

August 7, 2007

First Submitted That Met QC Criteria

August 7, 2007

First Posted (ESTIMATE)

August 8, 2007

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B84

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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