Dual-chamber Pacemaker PlacementPhase 3NCT01341522
Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System
A Phase 3 study testing MRI exam in people with Dual-chamber Pacemaker Placement, run by LivaNova.
Trial summary
Permanent cardiac pacemakers have represented a contraindication to Magnetic Resonance Imaging (MRI). Strong static, gradient and radiofrequency fields used for MRI are thought to be detrimental to pacemaker function and possibly cause harm to patients undergoing MRI examinations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dual-chamber Pacemaker Placement
- What is being tested?
- MRI exam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to May 2013
- Phase
- Phase 3
- 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
Who may be able to join
- Patients who are candidates for dual-chamber pacemaker primo-implantation
- Patients who have indication for implantation of a dual-chamber pacemaker according to the American College of Cardiology and the American Heart Association
- Patients who are able and willing to undergo elective MRI scanning
- Patients who are scheduled for implant of a Reply DR pacemaker and Filtrea lead(s) only
- Patients who provided signed and dated informed consent
Who cannot join
- Non MR-compatible device or material implant
- Chronic atrial fibrillation (for atrial lead evaluation)
- Incessant ventricular tachyarrhythmia (for ventricular lead evaluation)
- Inability to understand the purpose of the study or refusal to co-operate
- Unavailability for scheduled follow-ups at the implanting centre
- Already included in another clinical study that could affect the results of this study
Show all 12Show fewer
- Inability or refusal to provide informed consent
- Patient is minor (less than 18-year old)
- Patient is pregnant (women of childbearing potential should have a negative pregnancy test prior to enrolment);
- Patient has life expectancy of less than 1 year
- Patient is forfeiture of freedom or under guardianship
- Any patient to whom a contra-indication from device and lead labeling applies
About this study
Permanent cardiac pacemakers have represented a contraindication to Magnetic Resonance Imaging (MRI). Strong static, gradient and radiofrequency fields used for MRI are thought to be detrimental to pacemaker function and possibly cause harm to patients undergoing MRI examinations. A previous study has shown that MRI is indicated in 17% of all patients with pacemakers within 12 months of device placement , which demonstrates the need of practical, safe approach for performing MRI on pacemaker patients. A new Reply MR-conditional pacing system is developed by Sorin Group for safe use in the MRI environment. The new pacing system is composed by the Reply pacemaker and the Filtrea bradycardia pacing leads. This study intends to demonstrate the safety and the efficacy in the MRI environment of the Sorin Group Reply MR-conditional pacing system.
- Conditions
- Dual-chamber Pacemaker Placement
- Being tested
- MRI exam, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examProcedure or surgery
MRI exam
controlProcedure or surgery
waiting room
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control Receives: Procedure: control |
| MRI | Experimental | experimental Receives: Procedure: MRI exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the pacing system-, MRI- and implant procedure-related complication-free rate
Measured: 1 month
assess atrial and ventricular lead-related complication-free rate
Measured: 3 months
compare the changes in atrial and ventricular pacing thresholds before and after MRI, between MRI and control groups
Measured: 3 months
compare the changes in atrial and ventricular sense amplitude after MRI between MRI and control groups
Measured: 3 months
Secondary outcomes (3)
Summarize all implant procedure, pacing system- and MRI procedure-related adverse events
Measured: 12 months
Summarize atrial and ventricular electrical performances
Measured: 3 months
Summarize atrial and ventricular lead handling
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dual-chamber Pacemaker PlacementStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco LEYVA, Dr, Principal investigator, Queen Elizabeth BIRMINGHAM UNITED KINGDOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341522
- Sponsor's protocol ID
- IBMR01 - REPLY MRI STUDY
- Status last verified
- Jul 2013
- First submitted
- 1 Apr 2011
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
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
- Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System
- ClinicalTrials.gov ID
- NCT01341522
- Acronym / sponsor ID
- IBMR01 - REPLY MRI STUDY
- Conditions
- Dual-chamber Pacemaker Placement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 25 Apr 2011 (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.
Permanent cardiac pacemakers have represented a contraindication to Magnetic Resonance Imaging (MRI). Strong static, gradient and radiofrequency fields used for MRI are thought to be detrimental to pacemaker function and possibly cause harm to patients undergoing MRI examinations. A previous study has shown that MRI is indicated in 17% of all patients with pacemakers within 12 months of device placement , which demonstrates the need of practical, safe approach for performing MRI on pacemaker patients. A new Reply MR-conditional pacing system is developed by Sorin Group for safe use in the MRI environment. The new pacing system is composed by the Reply pacemaker and the Filtrea bradycardia pacing leads. This study intends to demonstrate the safety and the efficacy in the MRI environment of the Sorin Group Reply MR-conditional pacing system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: controlControl |
| MRI | Experimental | Procedure: MRI examexperimental |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are candidates for dual-chamber pacemaker primo-implantation
- Patients who have indication for implantation of a dual-chamber pacemaker according to the American College of Cardiology and the American Heart Association
- Patients who are able and willing to undergo elective MRI scanning
- Patients who are scheduled for implant of a Reply DR pacemaker and Filtrea lead(s) only
- Patients who provided signed and dated informed consent
Key exclusion criteria (12 listed)
- Non MR-compatible device or material implant
- Chronic atrial fibrillation (for atrial lead evaluation)
- Incessant ventricular tachyarrhythmia (for ventricular lead evaluation)
- Inability to understand the purpose of the study or refusal to co-operate
- Unavailability for scheduled follow-ups at the implanting centre
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 |
|---|---|---|
| MRI examMRI exam | Procedure or surgery | MRI |
| controlwaiting room | Procedure or surgery | Control |
Primary outcome
assess the pacing system-, MRI- and implant procedure-related complication-free rate
Time frame: 1 month
assess atrial and ventricular lead-related complication-free rate
Time frame: 3 months
compare the changes in atrial and ventricular pacing thresholds before and after MRI, between MRI and control groups
Time frame: 3 months
compare the changes in atrial and ventricular sense amplitude after MRI between MRI and control groups
Time frame: 3 months
3 secondary outcomes
Summarize all implant procedure, pacing system- and MRI procedure-related adverse events
Time frame: 12 months
Summarize atrial and ventricular electrical performances
Time frame: 3 months
Summarize atrial and ventricular lead handling
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
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.
Francisco LEYVA, Dr principal investigator
Queen Elizabeth BIRMINGHAM UNITED KINGDOM
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MRI exam in people with Dual-chamber Pacemaker Placement, run by LivaNova.
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 5 inclusion and 12 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: withdrawn, 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.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
assess the pacing system-, MRI- and implant procedure-related complication-free rate (time frame: 1 month). The study lists 4 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 17 Jul 2013.