INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI (INFINITE-MRI)
|ClinicalTrials.gov Identifier: NCT01890512|
Recruitment Status : Completed
First Posted : July 1, 2013
Results First Posted : June 5, 2014
Last Update Posted : February 5, 2016
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||INGENIO MRI/ FINELINE II ImageReadyTM Pacing System Data Collection in Patients Undergoing Magnetic Resonance Imaging|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
- 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:
- no episodes of asystole,
- no occurrence of sustained ventricular arrhythmias in the bore,
- no loss of capture due to rise in pacing threshold.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890512
|St. Antonius Ziekenhuis|
|Nieuwegein, Netherlands, 3435CM|