Clinical trial NCT01890512: INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI
Official title: INGENIO MRI/ FINELINE II ImageReadyTM Pacing System Data Collection in Patients Undergoing Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-07-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients implanted with a ImageReady pacemakers according to standard medical guidelines in the investigational site or referral centers

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.

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

Primary outcomes:
measure: Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Zwolle
country: Netherlands
facility: ISALA Klinieken
Study officials:
References: