Objective of the INFINITE 2 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…
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 2 MRI
family, includes purposeful design enhancements to allow exposure in the MR
environment under specific conditions of use. The use of the Ingenio 2 MRI
family of PMs together with INGEVITY MRI 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 September 2014 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 a 3 Tesla 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 2 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 3 Tesla 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 2 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 2 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 2 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 2* MRI pulse generators with INGEVITY MRI 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 |
|---|---|
| Other | Netherland trial register: candidate trial number 21093 (in course); clinicaltrials.gov (in coruse) |
| CCMO | NL51758.100.14 |