BradycardiaPhase 4SALTNCT00180570
SALT - Success of Active Versus Passive Lead Fixation of Atrial Pacing/Sensing Electrodes
A Phase 4 study testing FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ in people with Bradycardia, run by Guidant Corporation at 1 site in Sweden.
Trial summary
Randomised Comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ
- Type of treatment
- Medical device
- How many people
- 385 participants
- Where
- 1 siteSweden
- Study dates
- Jan 1997to Jan 2006
- Phase
- Phase 4
- 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
- Patients selected for participation in this investigation should be candidates for permanent pacemaker implantation chosen from the investigator's general patient population without regard for race or sex. Furthermore, these patients should, in the physician's general opinion, benefit from permanent pacemaker implantation with one of the study leads. Patients should be geographically stable and available for routine follow-up visits throughout the duration of the study. Patients must also be able and willing to provide informed consent.
Who cannot join
- Patients who previously went through heart surgery should be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scandinavian Atrial Lead Trial
Randomised Comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism
Read the detailed description
This investigation will study and compare 3 types of electrically identical, commercially available FineLine II Sterox leads with different fixation mechanisms. This trial has been designed to primarily study the difference in repositioning rate between active and passive fixation (straight and J-shaped) leads, if any. It will also monitor and document the behavior of the study leads, with special reference to electrical parameters and handling. Normal measurements are taken at pre-dicharge, 1-month 3-month and 12-month follow-up
- Conditions
- Bradycardia
- Being tested
- FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to compare repositioning rate due to threshold > 3.0 V @ 0.5 ms or P-wave < 0.8 mV between FineLine II Sterox 4480 and 4470, and between 4456 and 4470.
Secondary outcomes (1)
1. Other complications (Safety). To compare other lead related complication rates such as perforation, lead fracture and failure to implant. 2. Electrical properties
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 startJan 1997
- Study completionJan 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 participants
Sponsor and investigators
- Lead sponsor
- Guidant Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- charles kennergren, Principal investigator, Sahlgrenska Sjukhuset i Göteborg Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180570
- Sponsor's protocol ID
- SALT-2
- Acronym
- SALT
- Status last verified
- Sep 2005
- First submitted
- 15 Sep 2005
- Last updated
- 11 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scandinavian Atrial Lead Trial
- ClinicalTrials.gov ID
- NCT00180570
- Acronym / sponsor ID
- SALT / SALT-2
- Conditions
- Bradycardia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 385 participants
- Lead sponsor
- Guidant CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 1997
- Study completion
- Jan 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.
Randomised Comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism
Detailed description
This investigation will study and compare 3 types of electrically identical, commercially available FineLine II Sterox leads with different fixation mechanisms. This trial has been designed to primarily study the difference in repositioning rate between active and passive fixation (straight and J-shaped) leads, if any. It will also monitor and document the behavior of the study leads, with special reference to electrical parameters and handling. Normal measurements are taken at pre-dicharge, 1-month 3-month and 12-month follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients selected for participation in this investigation should be candidates for permanent pacemaker implantation chosen from the investigator's general patient population without regard for race or sex. Furthermore, these patients should, in the physician's general opinion, benefit from permanent pacemaker implantation with one of the study leads. Patients should be geographically stable and available for routine follow-up visits throughout the duration of the study. Patients must also be able and willing to provide informed consent.
Key exclusion criteria (1 listed)
- Patients who previously went through heart surgery should be excluded from the study.
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 |
|---|---|---|
| FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ | Device | – |
Primary outcome
The primary objective of this study is to compare repositioning rate due to threshold > 3.0 V @ 0.5 ms or P-wave < 0.8 mV between FineLine II Sterox 4480 and 4470, and between 4456 and 4470.
1 secondary outcome
1. Other complications (Safety). To compare other lead related complication rates such as perforation, lead fracture and failure to implant. 2. Electrical properties
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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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.
charles kennergren principal investigator
Sahlgrenska Sjukhuset i Göteborg Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ in people with Bradycardia, run by Guidant Corporation at 1 site in Sweden.
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: paused, as of the sponsor's last update on 11 Mar 2015. 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 Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
What does the primary outcome measure?
The primary objective of this study is to compare repositioning rate due to threshold > 3.0 V @ 0.5 ms or P-wave < 0.8 mV between FineLine II Sterox 4480 and 4470, and between 4456 and 4470.. It is what the study was designed to measure, not a finding.
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 11 Mar 2015.