INGENIO 2 /INGEVITY MRI device family data collection in patients undergoing Magnetic Resonance Imaging
Completed
- Conditions
- Pacemakers, Magnetic Resonance Imaging, hartritmestoornis,bradyaritmie
- Registration Number
- NL-OMON28451
- Lead Sponsor
- study sponsored by:Guidant Europe SA / NV,a Boston Scientific CompanyClinical CRM Department Green SquareLambroekstraat 5D 1831 Diegem, Belgium
- 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, 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 other cardiac-related implanted devices or accessories other than the ImageReadyTM MR Conditional Pacing System
• Low life expectancy (< 1 year)
• Severe comorbidities that, according to clinical judgment, pose patient at risk to undergo MRI
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The study is aimed at providing confirmatory data of 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.
- Secondary Outcome Measures
Name Time Method not applicable