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SCANCAP Scandinavian Automatic Capture Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180609
First Posted: September 16, 2005
Last Update Posted: April 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Guidant Corporation
  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

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180609


Locations
Denmark
Medicinsk Afdeling, Sygehus Viborg
Viborg, Denmark
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: Per D Christensen, MD Medicinsk Afdeling, Sygehus Viborg, Viborg, Denmark
  More Information

ClinicalTrials.gov Identifier: NCT00180609     History of Changes
Other Study ID Numbers: SCANCAP-1003
First Submitted: September 15, 2005
First Posted: September 16, 2005
Last Update Posted: April 23, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes