BradyarrhythmiaNCT01522755
Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
An observational study of Bradyarrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in France.
Trial summary
Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system. Success of a pacing lead implant can be defined considering 3 items: ease of lead implant, lead stability and lead electrical performances. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradyarrhythmia
- What is being tested?
- Pacing system implant with the CapsureFix MRI pacing lead model 5086
- Type of treatment
- Medical device
- How many people
- 409 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patient implanted with 2 CapsureFix MRI pacing leads model 5086 in the atrium and in the ventricle
Who may be able to join
- Patient older than 18
- Patient implanted with a fully automatic ICD and remotely followed-up,
- Patient geographically stable and able to attend FU at investigative site
- Patient who signed a data release authorization form,
Who cannot join
- Patient whose mental or physical capacity impedes to give an informed data release authorization,
- Patient already enrolled in a clinical study whose procedures may interfere with the results of the present study,
- Patients in New York Heart Association (NYHA) class IV
Trial locations and contacts
1 site in 1 country.
About this study
Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system.
Success of a pacing lead implant can be defined considering 3 items: ease of lead implant, lead stability and lead electrical performances.
Read more
These factors may be related to the physician experience (global implant experience, experience with a given lead), to the implant procedure (lead access, lead position, implant time, scopy time) to the lead (handling and mechanical characteristics) and to the patient (ischemic history).
Even though implant success rate is quite high with currently available leads, the weight of the different factors influencing success has never been studied systematically. The objective of the current study is then to define the predictive factors of an implant success with the CapsureFix MRI model 5086.
This lead has been selected because it has been available for a short period, so the investigators have a limited experience of it and it has a unique design which makes it conditionally safe in an MRI environment and which may be associated with specific handling characteristics.
- Conditions
- Bradyarrhythmia
- Being tested
- Pacing system implant with the CapsureFix MRI pacing lead model 5086
- Keywords
- Pacing lead, implant, pacemaker
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacing system implant with the CapsureFix MRI pacing lead model 5086Device
Pacing system implant with the CapsureFix MRI pacing lead model 5086
| Study group | Role | What they receive |
|---|---|---|
| Patients implanted with the CapsureFix MRI pacing lead | Patients implanted with the CapsureFix MRI pacing lead model 5086 Receives: Device: Pacing system implant with the CapsureFix MRI pacing lead model 5086 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Implant
Ease of implant as experienced by the implanting physician on maneuverability of the catheter. This was measured by a questionnaire for which each criterion was coded as Very Good, Good, Fair, Poor, Very Poor. Coding 9, 7, 5, 3, 1 was applied for each response with 9 representing Very Good. An average was calculated for each evaluation and for each probe implantation site.
Measured: at implant
Lead Stability
Lead stability of the Capsure Fix as measured by number of dislodgments
Measured: 3 months
Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086
Change of pacing threshold will be measured during and post implant of the CapsureFix MRI lead model 5086
Measured: 3 months
Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086
Change of sensing amplitude will be measured during and post implant of the CapsureFix MRI Lead Model 5086
Measured: 3 months
Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086
Change of impedance will be measured during and post implant of the CapsureFix MRI Lead Model 5086
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 posted1 Feb 2012 (estimated)
- Study startMay 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BradyarrhythmiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Olivier BIZEAU, MD, Principal investigator, Centre Hospitalier Regionnal d'Orléans La Source
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522755
- Sponsor's protocol ID
- 11
- Status last verified
- Jan 2020
- First submitted
- 11 Jan 2012
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
- ClinicalTrials.gov ID
- NCT01522755
- Acronym / sponsor ID
- 11
- Conditions
- Bradyarrhythmia
- Keywords
- Pacing lead, implant, pacemaker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- May 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system.
Success of a pacing lead implant can be defined considering 3 items: ease of lead implant, lead stability and lead electrical performances.
These factors may be related to the physician experience (global implant experience, experience with a given lead), to the implant procedure (lead access, lead position, implant time, scopy time) to the lead (handling and mechanical characteristics) and to the patient (ischemic history).
Even though implant success rate is quite high with currently available leads, the weight of the different factors influencing success has never been studied systematically. The objective of the current study is then to define the predictive factors of an implant success with the CapsureFix MRI model 5086.
This lead has been selected because it has been available for a short period, so the investigators have a limited experience of it and it has a unique design which makes it conditionally safe in an MRI environment and which may be associated with specific handling characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients implanted with the CapsureFix MRI pacing lead | – | Device: Pacing system implant with the CapsureFix MRI pacing lead model 5086Patients implanted with the CapsureFix MRI pacing lead model 5086 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient implanted with 2 CapsureFix MRI pacing leads model 5086 in the atrium and in the ventricle
Key inclusion criteria (4 listed)
- Patient older than 18
- Patient implanted with a fully automatic ICD and remotely followed-up,
- Patient geographically stable and able to attend FU at investigative site
- Patient who signed a data release authorization form,
Key exclusion criteria (3 listed)
- Patient whose mental or physical capacity impedes to give an informed data release authorization,
- Patient already enrolled in a clinical study whose procedures may interfere with the results of the present study,
- Patients in New York Heart Association (NYHA) class IV
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 system implant with the CapsureFix MRI pacing lead model 5086Pacing system implant with the CapsureFix MRI pacing lead model 5086 | Device | Patients implanted with the CapsureFix MRI pacing lead |
Primary outcome
Ease of Implant
Time frame: at implant
Ease of implant as experienced by the implanting physician on maneuverability of the catheter. This was measured by a questionnaire for which each criterion was coded as Very Good, Good, Fair, Poor, Very Poor. Coding 9, 7, 5, 3, 1 was applied for each response with 9 representing Very Good. An average was calculated for each evaluation and for each probe implantation site.
Lead Stability
Time frame: 3 months
Lead stability of the Capsure Fix as measured by number of dislodgments
Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086
Time frame: 3 months
Change of pacing threshold will be measured during and post implant of the CapsureFix MRI lead model 5086
Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086
Time frame: 3 months
Change of sensing amplitude will be measured during and post implant of the CapsureFix MRI Lead Model 5086
Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086
Time frame: 3 months
Change of impedance will be measured during and post implant of the CapsureFix MRI Lead Model 5086
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Olivier BIZEAU, MD principal investigator
Centre Hospitalier Regionnal d'Orléans La Source
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradyarrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in France.
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 2 Jul 2025. 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 France. 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?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ease of Implant (time frame: at implant). The study lists 5 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 2 Jul 2025.