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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38918

Enrollment

Registered

2013-05-23

Start date

2013-06-17

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnetic Resonance Imaging (MRI) Cardiac Rhythm disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion 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 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

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 (

Design outcomes

Primary

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

Countries

Netherlands

Outcome results