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SCANCAP Scandinavian Automatic Capture Study

Sponsor
Guidant Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00180609
Collaborator
(none)
203
Enrollment
1
Location
31
Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to document the success rate of the automatic threshold testat pre-discharge in a normal pacemaker patient population implanted with Guidant Insignia Ultra or AVT .

Condition or Disease Intervention/Treatment Phase
  • Device: Automatic threshold test in Insignia Pacemakers from Guidant

Detailed Description

Currently the optimal programming of the pacemaker output considers both pacemaker efficiency (prolonging battery longevity) and patient safety (adequate safety margin). A decrease in the programmed output can be used to increase the projected battery life or to eliminate diaphragmatic or pectoral muscle stimulation. An increase in programmed output may be required to account for increasing thresholds after lead implantation. The ability of an implanted pacemaker to automatically adjust the ventricular output above the pacing threshold while maintaining the appropriate safety margin has been explored since the early 1970s. The Automatic capture feature in the INSIGNIA I Ultra/AVT pacemaker automatically adapts the ventricular pacing output to ensure capture of the ventricle while optimizing the output voltage. The primary objective of this study is to document the success rate of the automatic threshold test in a normal pacemaker patient population by following normal pacemaker follow-up results for 1 year.

Study Design

Study Type:
Observational
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Scandinavian Automatic Capture Study
Study Start Date :
Dec 1, 2003
Study Completion Date :
Jul 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Suitable candidate for a INSIGNIA I Ultra or Insignia I AVT pacemaker (with a ventricular lead). Availability for follow-up at the centre. Willingness to participate in this study. Age 18 or above, or of legal age to give informed consent as specified by national law.
    Exclusion Criteria:
    • Inability or refusal to sign the Patient Informed Consent. Known pregnancy. Presence of mechanical tricuspid valve

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medicinsk Afdeling, Sygehus Viborg Viborg Denmark

    Sponsors and Collaborators

    • Guidant Corporation

    Investigators

    • Principal Investigator: Per D Christensen, MD, Medicinsk Afdeling, Sygehus Viborg, Viborg, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00180609
    Other Study ID Numbers:
    • SCANCAP-1003
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Apr 23, 2009
    Last Verified:
    Apr 1, 2009
    Additional relevant MeSH terms:
    Bradycardia

    Study Results

    No Results Posted as of Apr 23, 2009