Status:
COMPLETED
INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Bradycardia
Eligibility:
All Genders
18+ years
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™ ...
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 enr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01890512
Start Date
June 1 2013
End Date
January 1 2014
Last Update
February 5 2016
Active Locations (2)
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1
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435CM
2
ISALA Klinieken
Zwolle, Netherlands