INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI (INFINITE-MRI)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||INGENIO MRI/ FINELINE II ImageReadyTM Pacing System Data Collection in Patients Undergoing Magnetic Resonance Imaging|
- Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit [ Time Frame: one month ] [ Designated as safety issue: No ]
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.
|Study Start Date:||June 2013|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01890512
|St. Antonius Ziekenhuis|
|Nieuwegein, Netherlands, 3435CM|