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

Recruiting

Conditions: Magnetic resonance ImagingMR conditional pacemakersbradyarrhyhtmias

Registration Number: NL-OMON26814

Lead Sponsor: Giovanni RacitiClinical Trial ManagerPhone: +39 02 26983213E-mail: Giovanni.Raciti@bsci.com

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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, single or dual chamber, including INGENIO MRI or ADVANTIO MRI pulse generators with FINELINE II Sterox or FINELINE II Sterox EZ endocardial lead(s), according to standard medical guidelines for pacemaker implantation;

Exclusion Criteria

1. Patients implanted with pulse generator location outside of left or right pectoral regions;

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
o 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.<br><br /><br /><br>The study will collect standard device measurement through device interrogation pre- and post- MRI scan. Device measurements will include lead measurements (amplitude, threshold and impedance). <br><br /><br /><br>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 worldwide.

Secondary Outcome Measures