BradycardiaPhase 3NCT00180284
SITELINE 2 Polyurethane
A Phase 3 study testing SITELINE 2 Polyurethane (pacing lead) in people with Bradycardia, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- SITELINE 2 Polyurethane (pacing lead)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Feb 2008
- Phase
- Phase 3
- 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 indicated for dual chamber pulse generator implant, where the pulse generator is capable of meeting the requirements of this investigational protocol
- Patients selected must have the study lead as the initial implant of a permanent pacing lead in both the right atrium and the right ventricle
- Age 18 or above, or of legal age to give informed consent specific to state and national law
- Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
- Available for follow-up at an approved clinical investigational center, at the protocol-defined intervals
- A life expectancy of more than 180 days
Who cannot join
- Have or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation
- Have surgically uncorrected primary valvular heart disease
- Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously)
- Requiring ICD therapy
- Have a hypersensitivity to a nominal single dose of 1.0 mg (0.5 mg per electrode) of dexamethasone acetate drug
- Enrolled in any concurrent study, including drug investigation, without Guidant written approval, that may confound the results of this study
- Women who are pregnant or plan to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Multiple Locations in the United States
Saint Paul, Minnesota
About this study
Official title: SITELINE 2 Polyurethane Clinical Investigation
The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.
Read the detailed description
This was a prospective, single-arm, multi-center U.S. clinical investigation, designed to demonstrate the safety and effectiveness of the SITELINE 2 Polyurethane extendable, retractable pacing lead in humans
- Conditions
- Bradycardia
- Being tested
- SITELINE 2 Polyurethane (pacing lead)
- Keywords
- Pacemaker leads, Electrodes, implantable, Cardiac pacing, aritificial
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SITELINE 2 Polyurethane (pacing lead)Device
SITELINE 2 Polyurethane (pacing lead)
What is being measured
The primary outcome is the main question the study is designed to answer.
Pacing voltage threshold at 3 Months
Measured: 3 months
Pacing impedance at 3 Months
Measured: 3 months
Sensed amplitude at 3 Months
Measured: 3 months
Lead complication-free rate up to 3 Months
Measured: 3 months
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 startNov 2004
- Primary completionMay 2005
- Study completionFeb 2008
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.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180284
- Sponsor's protocol ID
- Clinicals0009
- Status last verified
- Sep 2011
- First submitted
- 9 Sep 2005
- Last updated
- 29 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SITELINE 2 Polyurethane Clinical Investigation
- ClinicalTrials.gov ID
- NCT00180284
- Acronym / sponsor ID
- Clinicals0009
- Conditions
- Bradycardia
- Keywords
- Pacemaker leads, Electrodes, implantable, Cardiac pacing, aritificial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- May 2005 (actual)
- Study completion
- Feb 2008 (actual)
- 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 SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.
Detailed description
This was a prospective, single-arm, multi-center U.S. clinical investigation, designed to demonstrate the safety and effectiveness of the SITELINE 2 Polyurethane extendable, retractable pacing lead in humans
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (6 listed)
- Patients indicated for dual chamber pulse generator implant, where the pulse generator is capable of meeting the requirements of this investigational protocol
- Patients selected must have the study lead as the initial implant of a permanent pacing lead in both the right atrium and the right ventricle
- Age 18 or above, or of legal age to give informed consent specific to state and national law
- Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
- Available for follow-up at an approved clinical investigational center, at the protocol-defined intervals
Key exclusion criteria (7 listed)
- Have or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation
- Have surgically uncorrected primary valvular heart disease
- Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously)
- Requiring ICD therapy
- Have a hypersensitivity to a nominal single dose of 1.0 mg (0.5 mg per electrode) of dexamethasone acetate drug
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 |
|---|---|---|
| SITELINE 2 Polyurethane (pacing lead)SITELINE 2 Polyurethane (pacing lead) | Device | – |
Primary outcome
Pacing voltage threshold at 3 Months
Time frame: 3 months
Pacing impedance at 3 Months
Time frame: 3 months
Sensed amplitude at 3 Months
Time frame: 3 months
Lead complication-free rate up to 3 Months
Time frame: 3 months
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 29 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SITELINE 2 Polyurethane (pacing lead) in people with Bradycardia, run by Boston Scientific Corporation at 1 site in United States.
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 6 inclusion and 7 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 29 Sep 2011. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Pacing voltage threshold at 3 Months (time frame: 3 months). The study lists 4 primary outcomes in all. 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 29 Sep 2011.