TachycardiaNCT01626768
Medtronic Market-Released DF4 Lead Imaging
An observational study of Tachycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in 2 countries.
Trial summary
The Medtronic Market-Released DF4 Lead Imaging Study is a prospective, non-randomized study, multi-center clinical investigation. The purpose of this clinical investigation is to collect high quality medical images of the Medtronic Market-Released DF4 lead in the shoulder and heart. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Tachycardia
- How many people
- 37 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2012to May 2013
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed at participating centers.
Who may be able to join
- Patients greater than 18 years of age.
- Patients able and willing to attend imaging session.
- Patients able and willing to give informed consent.
- Patients with an implanted device/lead(s) for a minimum of 3 months.
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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The Medtronic Market-Released DF4 Lead Imaging Study is a prospective, non-randomized study, multi-center clinical investigation.
The purpose of this clinical investigation is to collect high quality medical images of the Medtronic Market-Released DF4 lead in the shoulder and heart. Images collected during the study will allow for lead design and testing processes better tailored to the implanted environment.
- Conditions
- Tachycardia
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Enrolled patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vivo lead shape
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachycardiaStudies 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
- Time perspective
- Prospective
- Enrolment
- 37 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
- NCT01626768
- Sponsor's protocol ID
- DF4-Imaging-2012
- Status last verified
- Jul 2013
- First submitted
- 19 Jun 2012
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic Market-Released DF4 Lead Imaging
- ClinicalTrials.gov ID
- NCT01626768
- Acronym / sponsor ID
- DF4-Imaging-2012
- Conditions
- Tachycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Jun 2012 (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 Medtronic Market-Released DF4 Lead Imaging Study is a prospective, non-randomized study, multi-center clinical investigation.
The purpose of this clinical investigation is to collect high quality medical images of the Medtronic Market-Released DF4 lead in the shoulder and heart. Images collected during the study will allow for lead design and testing processes better tailored to the implanted environment.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled patients | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed at participating centers.
Key inclusion criteria (4 listed)
- Patients greater than 18 years of age.
- Patients able and willing to attend imaging session.
- Patients able and willing to give informed consent.
- Patients with an implanted device/lead(s) for a minimum of 3 months.
Key exclusion criteria (3 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In vivo lead shape
Time frame: Six 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 17 Jul 2013.
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Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
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AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
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Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in 2 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 4 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 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia, United Kingdom. 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?
In vivo lead shape (time frame: Six Months). 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 17 Jul 2013.