INGENIO 2 /INGEVITY MRI device family data collection in patients undergoing Magnetic Resonance Imaging

Phase 4

Completed

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

Registration Number: NL-OMON41793

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 2* MRI pulse generators with INGEVITY MRI 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<br /><br>impedance. The study has no primary endpoint and is not hypothesis driven.</p><br>

Secondary Outcome Measures