At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
INGEVITY™ Observational Trial: Assessment of Routine Experience and Magnet Resonance Imaging (MRI) Usage With a New Lead for Bradycardia Pacing
In Brief
An observational study evaluating ImageReady MR Conditional Pacing System Implant for Bradycardia. Completed, enrolled 1,184 participants across 60 sites in 13 countries.
Detailed Summary
The objectives of this registry are to 1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events 2. Gather data on actual number of MRI scans performed in the patient cohort implanted with an ImageReady system including information about scanned body parts. 3. Collect physician feedback on lead handling with the INGEVITY lead in a real-life, market-released standard of care environment using devices on intended purpose and which are authorized to bear the CE (Communauté Européenne) marking / are approved for use in the applicable area of participating centers. No additional invasive or other burdensome examinations are to be carried out other than the ones conducted by the centers per their general standard of care.
Study Details
Timeline
Interventions
Implant according to standard-of-care. No study-specific interventions in that registry.