Bradycardia
Conditions
Brief 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 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.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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.
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit | 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. |
Countries
Netherlands
Participant flow
Recruitment details
INFINITE MRI study started subject enrollment on 17 June 2013.Las subject was enrolled on 2 October 2013 and last subject follow up concluded on 17 January 2014. Study database was closed on 28 February 2014.
Participants by arm
| Arm | Count |
|---|---|
| ImageReady Pacemaker patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady) | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | ImageReady Pacemaker |
|---|---|
| Age, Continuous | 71.5 years STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 3 / 20 |
Outcome results
Primary
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: 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.
Time frame: one month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady Pacemaker | Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit | 0 number of MRI related patient adverse ev |