Heart DiseasesNCT03941275
SelectSecure 3830 Lead Imaging
An observational study of Heart Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in United States.
Trial summary
This study is designed to collect high-quality shoulder and intracardiac bi-plane fluoroscopic images during two standard arm motions on patients implanted with a market released SelectSecure 3830 lead for the purposes of developing a fracture reliability model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Bi-plane fluoroscopy
- How many people
- 51 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 May 2019to 15 Nov 2021
- 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
- Adult, Older adult
Study population: Subjects of both genders, 18 years of age and older that are currently implanted with at least one SelectSecure 3830 lead, regardless of device type and who meet all inclusion and no exclusion criteria are eligible for the study.
Who may be able to join
- Patients who are at least 18 years of age
- Patient has a pacing, ICD or CRT system incorporating at least one SelectSecure 3830 lead in the right atrium or right ventricle
- Patients able and willing to attend imaging session
- Patients able and willing to give informed consent
- Pacing capture threshold and pacing impedance of the lead are within normal range at the time of enrollment
- Patient must be able to accomplish arm flexion and adduction past 90 degrees
Who cannot join
- Subjects who require a legally authorized representative to obtain consent
- Subjects with exclusion criteria required by local law (e.g. age, breastfeeding)
- Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control
- Subjects that were implanted with a pacing, ICD, CRT device and/or cardiac leads less than three months ago
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Heart Center Research
Huntsville, Alabama, 35801
Associates in Cardiology PA
Silver Spring, Maryland, 20910
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043
Iowa Heart Center
West Des Moines, Iowa, 50266
About this study
This study is designed to collect high-quality shoulder and intracardiac bi-plane fluoroscopic images during two standard arm motions on patients implanted with a market released SelectSecure 3830 lead for the purposes of developing a fracture reliability model.
- Conditions
- Heart Diseases
- Being tested
- Bi-plane fluoroscopy
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-plane fluoroscopyDiagnostic test
In vivo acquisition of biplane cine radiographic images of the market released Medtronic SelectSecure 3830 pacing lead
| Study group | Role | What they receive |
|---|---|---|
| Subjects undergoing bi-plane fluoroscopy | Not described Receives: Diagnostic Test: Bi-plane fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect high quality shoulder and intracardiac bi-plane fluoroscopic cine images of the SelectSecure 3830 pacing lead.
Fluoroscopic cine images will be collected in conjunction with a specialized calibration object. When imaging data is processed and analyzed it will characterize the time-varying lead shape changes.
Measured: approximately 30 minutes
Secondary outcomes (1)
Acquire accelerometer-based motion data
During fluoroscopy of the two standard arm motions, accelerometer-based motion data will be collected which will allow matching of arm position with lead shape based on the fluoroscopic images.
Measured: approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start24 May 2019
- Primary completion3 Nov 2020
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941275
- Sponsor's protocol ID
- MDT18066
- Status last verified
- Mar 2022
- First submitted
- 1 May 2019
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SelectSecure 3830 Lead Imaging
- ClinicalTrials.gov ID
- NCT03941275
- Acronym / sponsor ID
- MDT18066
- Conditions
- Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 24 May 2019 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 7 May 2019 (actual)
- 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.
This study is designed to collect high-quality shoulder and intracardiac bi-plane fluoroscopic images during two standard arm motions on patients implanted with a market released SelectSecure 3830 lead for the purposes of developing a fracture reliability model.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects undergoing bi-plane fluoroscopy | – | Diagnostic Test: Bi-plane fluoroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects of both genders, 18 years of age and older that are currently implanted with at least one SelectSecure 3830 lead, regardless of device type and who meet all inclusion and no exclusion criteria are eligible for the study.
Key inclusion criteria (6 listed)
- Patients who are at least 18 years of age
- Patient has a pacing, ICD or CRT system incorporating at least one SelectSecure 3830 lead in the right atrium or right ventricle
- Patients able and willing to attend imaging session
- Patients able and willing to give informed consent
- Pacing capture threshold and pacing impedance of the lead are within normal range at the time of enrollment
Key exclusion criteria (4 listed)
- Subjects who require a legally authorized representative to obtain consent
- Subjects with exclusion criteria required by local law (e.g. age, breastfeeding)
- Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control
- Subjects that were implanted with a pacing, ICD, CRT device and/or cardiac leads less than three months ago
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 |
|---|---|---|
| Bi-plane fluoroscopyIn vivo acquisition of biplane cine radiographic images of the market released Medtronic SelectSecure 3830 pacing lead | Diagnostic test | Subjects undergoing bi-plane fluoroscopy |
Primary outcome
Collect high quality shoulder and intracardiac bi-plane fluoroscopic cine images of the SelectSecure 3830 pacing lead.
Time frame: approximately 30 minutes
Fluoroscopic cine images will be collected in conjunction with a specialized calibration object. When imaging data is processed and analyzed it will characterize the time-varying lead shape changes.
1 secondary outcome
Acquire accelerometer-based motion data
Time frame: approximately 30 minutes
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 15 Mar 2022.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites 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 4 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 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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?
Collect high quality shoulder and intracardiac bi-plane fluoroscopic cine images of the SelectSecure 3830 pacing lead. (time frame: approximately 30 minutes). 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 15 Mar 2022.