BradycardiaNCT00180609
SCANCAP Scandinavian Automatic Capture Study
An observational study of Bradycardia, run by Guidant Corporation at 1 site in Denmark.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Automatic threshold test in Insignia Pacemakers from Guidant
- Type of treatment
- Medical device
- How many people
- 203 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2003to Jul 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability or refusal to sign the Patient Informed Consent. Known pregnancy. Presence of mechanical tricuspid valve
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scandinavian Automatic Capture Study
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 .
Read the 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
- Being tested
- Automatic threshold test in Insignia Pacemakers from Guidant
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic threshold test in Insignia Pacemakers from GuidantDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2003
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants
Sponsor and investigators
- Lead sponsor
- Guidant Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Per D Christensen, MD, Principal investigator, Medicinsk Afdeling, Sygehus Viborg, Viborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180609
- Sponsor's protocol ID
- SCANCAP-1003
- Status last verified
- Apr 2009
- First submitted
- 15 Sep 2005
- Last updated
- 23 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scandinavian Automatic Capture Study
- ClinicalTrials.gov ID
- NCT00180609
- Acronym / sponsor ID
- SCANCAP-1003
- Conditions
- Bradycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants
- Lead sponsor
- Guidant CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- Jul 2006
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability or refusal to sign the Patient Informed Consent. Known pregnancy. Presence of mechanical tricuspid valve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic threshold test in Insignia Pacemakers from Guidant | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per D Christensen, MD principal investigator
Medicinsk Afdeling, Sygehus Viborg, Viborg, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by Guidant Corporation at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2009.