SCANCAP Scandinavian Automatic Capture Study
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Bradycardia |
Device: Automatic threshold test in Insignia Pacemakers from Guidant |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Scandinavian Automatic Capture Study |
| Estimated Enrollment: | 203 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | July 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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| Denmark | |
| Medicinsk Afdeling, Sygehus Viborg | |
| Viborg, Denmark | |
| Principal Investigator: | Per D Christensen, MD | Medicinsk Afdeling, Sygehus Viborg, Viborg, Denmark |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00180609 History of Changes |
| Other Study ID Numbers: | SCANCAP-1003 |
| Study First Received: | September 15, 2005 |
| Last Updated: | April 22, 2009 |
| Health Authority: | Denmark: National Board of Health |
Additional relevant MeSH terms:
|
Bradycardia Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013