ProMRI PROVEN Master Study

Launched by BIOTRONIK SE & CO. KG · Mar 12, 2013

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent
• • Able and willing to complete MRI testing
• • Able and willing to activate and use the Cardio Messenger
• • Able and willing to complete all testing required by the clinical protocol
• • Available for all follow-up visits at the investigational site
• • Standard indication for single, dual, or triple chamber ICD or CRT-P.
• • ICD or CRT-P system to be implanted in the pectoral region
• • Patient body height ≥ 140 cm
• • Age ≥ 18 years
• Exclusion Criteria:
• • Standard contraindication for single, dual, or triple chamber ICD or CRT-P.
• • Systems with an atrial lead: The patient has persistent (lasting longer than 7 days or requiring cardioversion) or permanent atrial arrhythmia
• • Patient has other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices
• • Patient has other metallic artifacts / components in body that may interact with MRI
• • Life expectancy of less than eight months
• • Cardiac surgery in the next eight months
• • Pregnant or breastfeeding
• • Enrolled in another non-observational cardiac clinical investigation