ImageReadyTM pacing system data collection in patients undergoing Magnetic Resonance Imaging.

INGENIO MRI/ FINELINE II ImageReadyTM pacing system data collection in patients undergoing Magnetic Resonance Imaging (INFINITE MRI).



Background of the research:

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, due to the potential for adverse effects. Boston Scientific INGENIO pacemakers and FINELINE II Sterox endocardial pacing leads (ImageReady™) have been labeled as a “MR Conditional Pacing System” when used in the MRI environment under the labeled Conditions of Use. 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 an MRI scan of key importance.



Objective of the research:

Objective of the INFINITE 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 undergoing a 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 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.



Study Design:

The INFINITE 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.



Study population:

Main inclusion criteria:

1. Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law;

2. Patients already implanted with ImageReady™ MR Conditional Pacing System, according to standard medical guidelines for pacemaker implantation;

3. Willing and capable of participation to the procedures indicated in the protocol.

Main exclusion criteria:

1. Patients implanted with other cardiac-related implanted devices or accessories other than the ImageReadyTM MR Conditional Pacing System;

2. Low life expectancy (< 1 year);

3. Severe comorbidities that, according to clinical judgment, pose patient at risk to undergo MRI.

The study is aimed at providing confirmatory data of no impact of magnetic resonance on pacemaker device function, lead parameters and patient conditions for the CE-marked ImageReady™ MR Conditional Pacing System (INGENIO MRI pacemaker + FINELINE II leads)when used under the labeled Conditions of Use.

1. Enrollment;

2. MRI visit;

3. One month follow up: 30 days +/-7 days after MRI visit.

There are no invasive interventions planned: INFINITE MRI Study collects 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. Patients will undergo a MRI scan not for diagnostic purposes under the labeled Conditions of Use.