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

Phase 4

Completed

Conditions: Magnetic Resonance Imaging (MRI)
Cardiac Rhythm disease
Bradyarrhyhtmia
10007521

Registration Number: NL-OMON38918

Lead Sponsor: Boston Scientific Cooperation International

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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 ImageReady* MR Conditional Pacing System, including INGENIO* MRI or ADVANTIO* MRI pulse generators with FINELINE* II Sterox endocardial lead(s), 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 pulse generators (PG)
• 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
• Women of childbearing potential who are or might be pregnant at the time of study enrollment or ImageReady MR Conditional Pacing System implant (method of assessment upon physician*s discretion)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study will collect standard device measurement through device interrogation<br /><br>done before MRI scan, post an MRI scan and at a 30 day follow up. Device<br /><br>measurement will include the following lead: amplitude, threshold and impedance.<br /><br><br /><br>The study has no primary endpoint and is not hypothesis driven.</p><br>

Secondary Outcome Measures