NCT00180609

SCANCAP Scandinavian Automatic Capture Study

Scandinavian Automatic Capture Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 203 (planned)
• Sponsor: Guidant Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

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.

Conditions

• Bradycardia

Interventions

Type	Name	Description
DEVICE	Automatic threshold test in Insignia Pacemakers from Guidant

Timeline

• Start date: 2003-12-01
• Completion: 2006-07-01
• First posted: 2005-09-16
• Last updated: 2009-04-23

Locations

1 site across 1 country: Denmark