This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

SCANCAP Scandinavian Automatic Capture Study

This study has been completed.
Information provided by:
Guidant Corporation Identifier:
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 .

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

Further study details as provided by Guidant Corporation:

Estimated Enrollment: 203
Study Start Date: December 2003
Estimated Study Completion Date: July 2006
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • Inability or refusal to sign the Patient Informed Consent. Known pregnancy. Presence of mechanical tricuspid valve
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00180609

Medicinsk Afdeling, Sygehus Viborg
Viborg, Denmark
Sponsors and Collaborators
Guidant Corporation
Principal Investigator: Per D Christensen, MD Medicinsk Afdeling, Sygehus Viborg, Viborg, Denmark
  More Information Identifier: NCT00180609     History of Changes
Other Study ID Numbers: SCANCAP-1003
Study First Received: September 15, 2005
Last Updated: April 22, 2009

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on September 21, 2017