BradycardiaINFINITE-MRINCT01890512
INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI
An observational study of Bradycardia, run by Boston Scientific Corporation at 2 sites in Netherlands.
Trial summary
The INFINITE MRI Study is a prospective, non-randomized, multicenter, single arm study aimed at collecting data on ImageReady™ MR Conditional Pacing System (consisting of an INGENIO™ MRI or ADVANTIO™ MRI pacemaker with FINELINE™ II Sterox or FINELINE™ II Sterox EZ endocardial pacing lead(s)) when used in the Magnetic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jun 2013to Jan 2014
- 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: patients implanted with a ImageReady pacemakers according to standard medical guidelines in the investigational site or referral centers
Who may be able to join
- Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law;
- Patients already implanted with the ImageReady™ MR Conditional Pacing System, single or dual chamber, including INGENIO™ MRI or ADVANTIO™ MRI pulse generators with FINELINE™ II Sterox or FINELINE II Sterox EZ endocardial lead(s), or accessories (see Table 5.1-1) according to standard medical guidelines for pacemaker implantation;
- Willing and capable of participation to the procedures indicated in the protocol.
Who cannot join
- Patients implanted with pulse generator location outside of left or right pectoral regions;
- Patients implanted with other cardiac-related implanted devices or accessories other than the ImageReadyTM MR Conditional Pacing System;
- Abandoned leads or PGs;
- Evidence of a fractured lead or compromised PG-lead system integrity;
- Low life expectancy (< 1 year);
- Severe comorbidities that, according to clinical judgment, pose patient at risk to undergo MRI;
- Pregnant women or women of childbearing potential
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
St. Antonius Ziekenhuis
Nieuwegein, 3435CM
ISALA Klinieken
Zwolle
About this study
Official title: INGENIO MRI/ FINELINE II ImageReadyTM Pacing System Data Collection in Patients Undergoing Magnetic Resonance Imaging
The INFINITE MRI Study is a prospective, non-randomized, multicenter, single arm study aimed at collecting data on ImageReady™ MR Conditional Pacing System (consisting of an INGENIO™ MRI or ADVANTIO™ MRI pacemaker with FINELINE™ II Sterox or FINELINE™ II Sterox EZ endocardial pacing lead(s)) when used in the Magnetic Resonance Imaging environment under the labeled Conditions of Use.
Read the detailed description
Objective of the INFINITE MRI Study is to collect data on the ImageReady MR Conditional Pacing System in subjects undergoing a magnetic resonance scan (MRI).
The ImageReady system has CE mark and enrolled patients will undergo MRI scan under the labeled Conditions of Use. Subjects considered eligible for this studty are already implanted with the system according to standard medical guidelines for PM implantation.
The study is aimed at providing confirmatory data of no impact of MRI on device function, lead parameters and patient conditions. The study will collect standard device measurement through device interrogation pre- and post- MRI scan. MRI scan in this study is a non-clinically indicated procedure and is not planned for diagnostic purposes.
Data from this study will be used to support the evidence of clinical performance of the ImageReady™ MR Conditional Pacing System following a MRI scan when used under the labeled Conditions of Use, and may be used to support regulatory submissions for the approval of the system where requested.
The study has no primary endpoint and is not hypothesis driven.
- Conditions
- Bradycardia
- Medical subject headings
- Bradycardia
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 |
|---|---|---|
| ImageReady Pacemaker | patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit
The study is aimed at providing confirmatory data of no impact of MRI on device function and patient conditions.
Confirmation of no MRI related patient adverse events and/or adverse device effects during MRI visit are assessed as follows:
- no episodes of asystole,
- no occurrence of sustained ventricular arrhythmias in the bore,
- no loss of capture due to rise in pacing threshold.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionJan 2014
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 BradycardiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890512
- Sponsor's protocol ID
- C1897
- Acronym
- INFINITE-MRI
- Status last verified
- May 2014
- First submitted
- 25 Jun 2013
- Last updated
- 5 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INGENIO MRI/ FINELINE II ImageReadyTM Pacing System Data Collection in Patients Undergoing Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01890512
- Acronym / sponsor ID
- INFINITE-MRI / C1897
- Conditions
- Bradycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Jul 2013 (estimated)
- Results
- Posted 5 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The INFINITE MRI Study is a prospective, non-randomized, multicenter, single arm study aimed at collecting data on ImageReady™ MR Conditional Pacing System (consisting of an INGENIO™ MRI or ADVANTIO™ MRI pacemaker with FINELINE™ II Sterox or FINELINE™ II Sterox EZ endocardial pacing lead(s)) when used in the Magnetic Resonance Imaging environment under the labeled Conditions of Use.
Detailed description
Objective of the INFINITE MRI Study is to collect data on the ImageReady MR Conditional Pacing System in subjects undergoing a magnetic resonance scan (MRI).
The ImageReady system has CE mark and enrolled patients will undergo MRI scan under the labeled Conditions of Use. Subjects considered eligible for this studty are already implanted with the system according to standard medical guidelines for PM implantation.
The study is aimed at providing confirmatory data of no impact of MRI on device function, lead parameters and patient conditions. The study will collect standard device measurement through device interrogation pre- and post- MRI scan. MRI scan in this study is a non-clinically indicated procedure and is not planned for diagnostic purposes.
Data from this study will be used to support the evidence of clinical performance of the ImageReady™ MR Conditional Pacing System following a MRI scan when used under the labeled Conditions of Use, and may be used to support regulatory submissions for the approval of the system where requested.
The study has no primary endpoint and is not hypothesis driven.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ImageReady Pacemaker | – | –patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients implanted with a ImageReady pacemakers according to standard medical guidelines in the investigational site or referral centers
Key inclusion criteria (3 listed)
- Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law;
- Patients already implanted with the ImageReady™ MR Conditional Pacing System, single or dual chamber, including INGENIO™ MRI or ADVANTIO™ MRI pulse generators with FINELINE™ II Sterox or FINELINE II Sterox EZ endocardial lead(s), or accessories (see Table 5.1-1) according to standard medical guidelines for pacemaker implantation;
- Willing and capable of participation to the procedures indicated in the protocol.
Key exclusion criteria (7 listed)
- Patients implanted with pulse generator location outside of left or right pectoral regions;
- Patients implanted with other cardiac-related implanted devices or accessories other than the ImageReadyTM MR Conditional Pacing System;
- Abandoned leads or PGs;
- Evidence of a fractured lead or compromised PG-lead system integrity;
- Low life expectancy (< 1 year);
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
Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit
Time frame: one month
The study is aimed at providing confirmatory data of no impact of MRI on device function and patient conditions. Confirmation of no MRI related patient adverse events and/or adverse device effects during MRI visit are assessed as follows: 1. no episodes of asystole, 2. no occurrence of sustained ventricular arrhythmias in the bore, 3. no loss of capture due to rise in pacing threshold.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bradycardia
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
RecruitingObservational study
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Pacemaker, Leadless Pacemaker
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by Boston Scientific Corporation at 2 sites in Netherlands.
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 3 inclusion and 7 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 5 Feb 2016. 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 Netherlands. 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 5 Jun 2014). 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?
Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit (time frame: one month). 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 5 Feb 2016.