Pacing Leads ImplantationXFine & BeflexNCT01168518
An Observational Study on the Sorin Group New Brady Leads XFine and Beflex
An observational study of Pacing Leads Implantation, run by LivaNova at 1 site in France.
Trial summary
This observational study is a non-interventional multi-centre, prospective study. The aim of the study is to evaluate the Sorin Group new passive- and active- fixation pacing leads. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacing Leads Implantation
- How many people
- 2,254 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2008to Sep 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Any patient implanted with an endocavitary pacing lead (atrial and/or ventricular) connected to a single, double or triple chamber pacemaker or defibrillator.
Who may be able to join
- The implanted lead must allow the measurement of pacing threshold at 0.5ms, R-wave or P-wave amplitude and impedance of the lead.
- Included patients may receive more than one lead under evaluation.
Who cannot join
- Any contraindication to endocavitary lead implantation;
- Inability to understand the purpose of the study or refusal to co-operate.
- Geographically unstable or unavailability for scheduled M1-M3 follow-up at the implanting centre as defined in the investigational plan.
- Patient of minor age (<18)
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of the New Generation of Sorin Group Brady Leads In a Normal Hospital Practice
This observational study is a non-interventional multi-centre, prospective study.
The aim of the study is to evaluate the Sorin Group new passive- and active- fixation pacing leads. We plan to assess the acute and short term lead dislodgment rate (within the first three months following implantation) correlated with the type of lead (active- or passive- fixation). Further, we are collecting data related to leads handling and leads electrical performances
Read the detailed description
The primary objective of this observational study is to assess the acute rate of dislodgment of the new Sorin group range of active- and passive- fixation leads up to 3 months following implant.
Assessment of electrical performances (pacing threshold, sensing amplitude, impedance) of the leads at implant and during follow-up.
- Conditions
- Pacing Leads Implantation
- Keywords
- Evaluate the Sorin Group new passive- and active- fixation pacing leads
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead dislodgment rate in acute phase
Ventricular active fixation leads = 1.57%; Ventricular passive fixation leads = 3.23%, Atrial active fixation leads = 1.04%
Measured: Lead dislodgment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startJul 2008
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacing Leads ImplantationStudies of the same condition, open and under way.
- 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
- 2,254 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henri Benkemoun, MD, Principal investigator, Unité de Cardiologie et Rythmologie Interventionelle, Perpignan France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168518
- Sponsor's protocol ID
- RLEA01-FINE
- Other IDs
- RLEA01
- Acronym
- XFine & Beflex
- Status last verified
- Sep 2014
- First submitted
- 22 Jul 2010
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the New Generation of Sorin Group Brady Leads In a Normal Hospital Practice
- ClinicalTrials.gov ID
- NCT01168518
- Acronym / sponsor ID
- XFine & Beflex / RLEA01-FINE
- Conditions
- Pacing Leads Implantation
- Keywords
- Evaluate the Sorin Group new passive- and active- fixation pacing leads
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,254 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 Jul 2010 (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.
This observational study is a non-interventional multi-centre, prospective study.
The aim of the study is to evaluate the Sorin Group new passive- and active- fixation pacing leads. We plan to assess the acute and short term lead dislodgment rate (within the first three months following implantation) correlated with the type of lead (active- or passive- fixation). Further, we are collecting data related to leads handling and leads electrical performances
Detailed description
The primary objective of this observational study is to assess the acute rate of dislodgment of the new Sorin group range of active- and passive- fixation leads up to 3 months following implant.
Assessment of electrical performances (pacing threshold, sensing amplitude, impedance) of the leads at implant and during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient implanted with an endocavitary pacing lead (atrial and/or ventricular) connected to a single, double or triple chamber pacemaker or defibrillator.
Key inclusion criteria (2 listed)
- The implanted lead must allow the measurement of pacing threshold at 0.5ms, R-wave or P-wave amplitude and impedance of the lead.
- Included patients may receive more than one lead under evaluation.
Key exclusion criteria (5 listed)
- Any contraindication to endocavitary lead implantation;
- Inability to understand the purpose of the study or refusal to co-operate.
- Geographically unstable or unavailability for scheduled M1-M3 follow-up at the implanting centre as defined in the investigational plan.
- Patient of minor age (<18)
- Pregnancy.
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
Lead dislodgment rate in acute phase
Time frame: Lead dislodgment
Ventricular active fixation leads = 1.57%; Ventricular passive fixation leads = 3.23%, Atrial active fixation leads = 1.04%
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 2014.
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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.
Henri Benkemoun, MD principal investigator
Unité de Cardiologie et Rythmologie Interventionelle, Perpignan France
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 Pacing Leads Implantation, run by LivaNova 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 2 inclusion and 5 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 2014. 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?
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?
Lead dislodgment rate in acute phase (time frame: Lead dislodgment). 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 2014.