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

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00512915
First received: August 7, 2007
Last updated: March 4, 2009
Last verified: March 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
Bradycardia
 Device: pacemaker implantation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Atriale Vorhofsonde 1699 Mit Sehr Kurzem Bipolabstand Zur Vermeidung Von Far Field Sensing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of inappropriate mode switch in respect to lead position and ventricular stimulation frequency [ Time Frame: 1 and 3 months post implantation ] [ Designated as safety issue: No ]
  • Atrial Flutter in stored EGM's [ Time Frame: 1 and 3 months post implantation ] [ Designated as safety issue: No ]
  • 2:1 lock in of Atrial Flutter [ Time Frame: 1 and 3 months post implantation ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: December 2006
Study Completion Date: August 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512915

Locations
Germany
Klinikum Coburg
Coburg, Germany, 96450
Klinik Fränkische Schweiz
Ebermannstadt, Germany, 91320
Kreisklinik Ebersberg
Ebersberg, Germany, 85560
Krankenhaus Waltershausen-Friedrichroda
Friedrichroda, Germany, 99894
Universitäres Herzzentrum Hamburg
Hamburg, Germany, 20246
Klinikum Memmingen
Memmingen, Germany, 87700
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Kardiologische Praxis Dres. med. Bödigheimer / Mühling / Prof. Dr. med. Silber
München, Germany, 80331
Kreiskrankenhaus Ottweiler
Ottweiler, Germany, 66564
Universitätsklinikum Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Christof Kolb, MD Deutsches Herzzentrum Muenchen
  More Information

No publications provided by St. Jude Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jörg Scheiner, St. Jude Medical GmbH
ClinicalTrials.gov Identifier: NCT00512915     History of Changes
Other Study ID Numbers: B84
Study First Received: August 7, 2007
Last Updated: March 4, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by St. Jude Medical:
Farfield Sensing
Pacing lead
Postventricular atrial blanking
Bradycardia

Additional relevant MeSH terms:
Atrial Fibrillation
Bradycardia
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013