Objective of the INFINITE MRI Study is to collect data on the ImageReady* MR Conditional Pacing System in subjects already implanted with the system according to standard medical guidelines for PM implantation and meets the labeled MRI Conditions of…
ID
Source
Brief title
Condition
- Other condition
- Cardiac arrhythmias
Synonym
Health condition
Magnetic Resonance Imaging (MRI)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study will collect standard device measurement through device interrogation
done before MRI scan, post an MRI scan and at a 30 day follow up. Device
measurement will include the following lead: amplitude, threshold and impedance.
The study has no primary endpoint and is not hypothesis driven.
Secondary outcome
Not applicable
Background summary
Magnetic resonance imaging (MRI) is now the imaging modality of choice for many
neurological and musculoskeletal conditions. In the past, implanted cardiac
devices including pacemakers (PM) have been contraindicated by MRI scanner
labeling, due to the potential for adverse effects including elevated pacing
thresholds; failure of capture due to tissue heating at the tip of the
endocardial pacing lead and induced arrhythmias due to unintended cardiac
stimulation. New generations of PMs have been designed to allow patients to
have a MRI scan under certain conditions of use and have been labeled as MR
Conditional. Boston Scientific*s (BSC) new generation of PMs, the Ingenio MRI
family, includes purposeful design enhancements to allow exposure in the MR
environment under specific conditions of use. The use of the Ingenio MRI family
of PMs together with FINELINETM II Sterox family of endocardial pacing leads
has been labeled as a *MR Conditional Pacing System* when used in the MRI
environment under the labeled Conditions of Use. Ingenio MRI PM family received
CE Mark in July 2012 and interest in collecting human data to confirm
performance of this pacing system when used in MRI environments is high, with
the collection of data from patients undergoing an MRI scan of key importance.
However, despite the fact that it has been reported up to 17% of PM patients
are indicated for MRI within an year of pacemaker implant, the availability of
supportive clinical data is limited. For this reason, and in light of the
interest from regulatory and healthcare bodies world-wide, data prospectively
obtained from PM patients who undergo a MRI scan has been requested to support
the use of MR Conditional systems. Such data can be collected in medical
facilities that have already implanted the MR Conditional pacing system simply
by confirming proper device function following a dedicated MRI scan sequence
not designed for the purposes of diagnosis.
Study objective
Objective of the INFINITE MRI Study is to collect data on the ImageReady* MR
Conditional Pacing System in subjects already implanted with the system
according to standard medical guidelines for PM implantation and meets the
labeled MRI Conditions of Use, undergoing a MRI scan under the labeled
Conditions of Use.
The study is aimed at providing confirmatory data of no impact of MRI on device
function, lead parameters and patient conditions for the CE-marked ImageReady*
MR Conditional Pacing System when used under the labeled Conditions of Use.
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. Device measurements will
include lead measurements (amplitude, threshold and impedance).
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 worldwide.
Study design
The INFINITE MRI Study is a prospective, non-randomized non-blinded,
multicenter, single arm study. Study will enroll up to 20 subjects at
approximately two centers in Europe, who agree to participate in the study by
signing informed consent, will undergo a MRI scan and perform a device follow
up at one month.
Study burden and risks
Risks: subjects that will be enrolled in the INFINITE MRI Study are patients
already implanted with with ImageReady* MR Conditional Pacing System according
to standard medical guidelines for PM implantation. All measurements indicated
in this protocol are done according to approved labeling for the ImageReady* MR
Conditional Pacing System. MRI in patients implanted with the ImageReady* MR
Conditional Pacing System is considered safe when complying with Conditions of
Use as indicated both in the labeling and in this study protocol. Known
adverse events associated with the ImageReady* MR Conditional Pacing System
when undergoing MRI under the labeled Conditions of Use are extremely rare and
none is anticipated to occur in the limited sample of this study. Other risks
associated to MRI and not specifically related to the ImageReady* system are
extremely rare provided that appropriate precautions are followed according to
radiology standards. Risks are additionally mitigated by appropriate patient
selection according to the criteria of the present protocol and by using
non-invasive procedure (no vein puncture, no contrast enhancing agents), unless
needed for specific MR diagnostic purposes, that are not part of the present
study.
Benefits: with respect to MRI scanning, no diagnostic data will be generated by
the MRI scan in the INFINITE MRI study, unless (a) an MRI indication for the
patient already exists or (b) according to site indications and/or patient
decision. Therefore, there should be no direct benefit for the patient in
participating to this study. Data from this study will however, generate
confirmatory evidence of no impact of MRI on standard device function of the
CE-marked ImageReady* MR Conditional Pacing Systems confirming the clinical
safety and performance of the system and potentially providing evidence to
support regulatory approval of the system in other geographies worldwide.
Green Square Lambroekstraat 5D
Diegem 1831
BE
Green Square Lambroekstraat 5D
Diegem 1831
BE
Listed location countries
Age
Inclusion criteria
• Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law
• Patients already implanted with ImageReady* MR Conditional Pacing System, including INGENIO* MRI or ADVANTIO* MRI pulse generators with FINELINE* II Sterox endocardial lead(s), according to standard medical guidelines for pacemaker implantation.
• Willing and capable of participation to the procedures indicated in the protocol.
Exclusion criteria
• 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 pulse generators (PG)
• 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
• Women of childbearing potential who are or might be pregnant at the time of study enrollment or ImageReady MR Conditional Pacing System implant (method of assessment upon physician*s discretion)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43816.100.13 |
| Other | NTR3874 + ongoing www.clinicaltrials.gov |