SCANCAP Scandinavian Automatic Capture Study
This study has been completed.
Information provided by:
First received: September 15, 2005
Last updated: April 22, 2009
Last verified: April 2009
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 .
Device: Automatic threshold test in Insignia Pacemakers from Guidant
||Observational Model: Cohort
Time Perspective: Prospective
||Scandinavian Automatic Capture Study
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Inability or refusal to sign the Patient Informed Consent. Known pregnancy. Presence of mechanical tricuspid valve
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00180609
|Medicinsk Afdeling, Sygehus Viborg
|Viborg, Denmark |
||Per D Christensen, MD
||Medicinsk Afdeling, Sygehus Viborg, Viborg, Denmark
No publications provided
ClinicalTrials.gov processed this record on March 03, 2015
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 15, 2005
||April 22, 2009
||Denmark: National Board of Health