SCANCAP Scandinavian Automatic Capture Study

Bradycardia Clinical Trial

Official title:

Scandinavian Automatic Capture Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180609
• Other study ID #: SCANCAP-1003
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2005
• Last updated: April 22, 2009
• Start date: December 2003
• Est. completion date: July 2006

Study information

• Verified date: April 2009
• Source: Guidant Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• Automatic threshold test in Insignia Pacemakers from Guidant

Locations

Country	Name	City	State
Denmark	Medicinsk Afdeling, Sygehus Viborg	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
Guidant Corporation

Country where clinical trial is conducted

Denmark,