BradycardiaNCT00266682
Clinical Investigation of the SelectSecure Pacing Lead
A study testing Pacing Lead in people with Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 31 sites in 3 countries.
Trial summary
People who have a slow heart beat, or whose heart does not beat on its own, may be in need of an electronic device called a pacemaker. A pacemaker is implanted surgically just under the skin in the upper chest area. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Pacing Lead
- Type of treatment
- Medical device
- How many people
- 365 participants
- Where
- 31 sitesin 3 countries
- Study dates
- Aug 2002to Aug 2005
- Phase
- Interventional
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who are in need of a pacemaker that paces in both the right atrium and ventricle.
Who cannot join
- Subjects who are in need of an implantable cardioverter defibrillator (ICD).
- Subjects who have a mechanical or diseased tricuspid valve (a structure in the heart, located between the right atrium and right ventricle, which allows blood to flow from the atrium to the ventricle).
- Steroid contraindication
Trial locations and contacts
31 sites in 3 countries.
31 sites in 3 countries
United States26 sites
Study site
Anchorage, Alaska
Study site
Austin, Texas
Study site
Boston, Massachusetts
Study site
Cincinnati, Ohio
Study site
Des Moines, Iowa
Study site
Detroit, Michigan
Study site
Evanston, Illinois
Study site
Fort Lauderdale, Florida
Study site
Germantown, Tennessee
Study site
Indianapolis, Indiana
Study site
Iowa City, Iowa
Study site
Kansas City, Kansas
Study site
Kansas City, Missouri
Study site
Lancaster, Pennsylvania
Study site
Livingston, New Jersey
Study site
Long Beach, California
Study site
Nashville, Tennessee
Study site
Peoria, Arizona
Study site
Richmond, Virginia
Study site
Robbinsdale, Minnesota
Study site
Saint Paul, Minnesota
Study site
Santa Rosa, California
Study site
Sayre, Pennsylvania
Study site
Springfield, Missouri
Study site
Temple, Texas
Study site
Winston-Salem, North Carolina
Canada4 sites
Study site
Kingston
Study site
London
Study site
Ottawa
Study site
Sainte-Foy
About this study
People who have a slow heart beat, or whose heart does not beat on its own, may be in need of an electronic device called a pacemaker. A pacemaker is implanted surgically just under the skin in the upper chest area. This device helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. The purpose of this study is to demonstrate that the SelectSecure (Model 3830) lead is safe and effective for both sensing the heart's natural rhythm and pacing the heart when it does not beat on its own. This lead will be studied in both the right atrium and right ventricle. A previously market approved Medtronic lead model will serve as a comparison to prove the safety and effectiveness of the SelectSecure Model.
- Conditions
- Bradycardia
- Being tested
- Pacing Lead
- Keywords
- Bradycardia
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacing LeadDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives
Secondary outcomes (1)
Lead and catheter handling characteristics, and lead impedance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2005 (estimated)
- Study startAug 2002
- Study completionAug 2005
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 Medtronic Cardiac Rhythm and Heart FailureThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 365 participants
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266682
- Sponsor's protocol ID
- 600
- Status last verified
- Oct 2006
- First submitted
- 16 Dec 2005
- Last updated
- 13 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the SelectSecure Pacing Lead
- ClinicalTrials.gov ID
- NCT00266682
- Acronym / sponsor ID
- 600
- Conditions
- Bradycardia
- Keywords
- Bradycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Aug 2005
- First posted
- 19 Dec 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.
People who have a slow heart beat, or whose heart does not beat on its own, may be in need of an electronic device called a pacemaker. A pacemaker is implanted surgically just under the skin in the upper chest area. This device helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. The purpose of this study is to demonstrate that the SelectSecure (Model 3830) lead is safe and effective for both sensing the heart's natural rhythm and pacing the heart when it does not beat on its own. This lead will be studied in both the right atrium and right ventricle. A previously market approved Medtronic lead model will serve as a comparison to prove the safety and effectiveness of the SelectSecure Model.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who are in need of a pacemaker that paces in both the right atrium and ventricle.
Key exclusion criteria (3 listed)
- Subjects who are in need of an implantable cardioverter defibrillator (ICD).
- Subjects who have a mechanical or diseased tricuspid valve (a structure in the heart, located between the right atrium and right ventricle, which allows blood to flow from the atrium to the ventricle).
- Steroid contraindication
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 |
|---|---|---|
| Pacing Lead | Device | – |
Primary outcome
3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives
1 secondary outcome
Lead and catheter handling characteristics, and lead impedance
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 13 Oct 2006.
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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.
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacing Lead in people with Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 31 sites in 3 countries.
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 3 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 13 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada, Australia. 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.
What does the primary outcome measure?
3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives. 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 13 Oct 2006; AzTrials last refreshed its copy on 7 Nov 2026.