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CompletedNCT00180609Updated Apr 23, 2009

SCANCAP Scandinavian Automatic Capture Study

An observational study in Bradycardia, sponsored by Guidant Corporation. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-04-23.

Sponsored by Guidant Corporation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
203
Ages
18 Years and older
Sex
All
01

Study 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 .

Read the 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.

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Conditions studied

  • Bradycardia

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03

In context

Bradycardia

306 studies on the registry are indexed under Bradycardia; 69 are open to participants now.

This study's enrollment of 203 is below the median of 257 across 129 observational studies indexed under Bradycardia.

Browse Bradycardia studies →

Lead sponsor

Guidant Corporation is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Inability or refusal to sign the Patient Informed Consent. Known pregnancy. Presence of mechanical tricuspid valve
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
203 participants

Interventions

  • DeviceAutomatic threshold test in Insignia Pacemakers from Guidant
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Study locations

1 site
  • Medicinsk Afdeling, Sygehus Viborg
    Viborg, Denmark
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00180609
Lead sponsor
Guidant Corporation
First posted
Sep 16, 2005
Start date
Dec 2003
Completion
Jul 2006
Last update
Apr 23, 2009

Study contacts

Per D Christensen, MD
principal investigator · Medicinsk Afdeling, Sygehus Viborg, Viborg, Denmark
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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