INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI

Launched by BOSTON SCIENTIFIC CORPORATION · Jun 27, 2013

Keywords

ClinConnect Summary

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 measurem...

Gender

ALL

Eligibility criteria

• 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