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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26814

Enrollment

Registered

2013-02-25

Start date

2013-04-15

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Magnetic resonance Imaging MR conditional pacemakers bradyarrhyhtmias

Interventions

There are no invasive interventions planned: INFINITE MRI Study collects data on the ImageReady™ MR Conditional Pacing System in subjects already implanted with the system according to standard medica

Eligibility

Inclusion criteria

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; 3. Willing and capable of participation to the procedures indicated in the protocol.

Exclusion criteria

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; 3. Abandoned leads or pulse generators (PG); 4. Evidence of a fractured lead or compromised PG-lead system integrity; 5. Low life expectancy (< 1 year); 6. Severe comorbidities that, according to investigator clinical judgment, pose patient risk to undergo MRI; 7. Pregnant women or women of childbearing potential.

Design outcomes

Primary

Measure	Time frame
No 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. 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). 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.	—

Measure

Time frame

No 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. 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). 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.

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Contacts

Public ContactLucas V.A. Boersma

St. Antonius Ziekenhuis Koekoekslaan 1

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)