NCT02166606

INGEVITY™ Observational Trial

INGEVITY™ Observational Trial: Assessment of Routine Experience and Magnet Resonance Imaging (MRI) Usage With a New Lead for Bradycardia Pacing

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,184 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bradycardia

Interventions

Type	Name	Description
DEVICE	ImageReady MR Conditional Pacing System Implant	Implant according to standard-of-care. No study-specific interventions in that registry.

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-06-01
• Completion: 2016-09-01
• First posted: 2014-06-18
• Last updated: 2021-03-30
• Results posted: 2019-08-20

Locations

60 sites across 13 countries: Austria, Belgium, France, Germany, Ireland, Italy, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom