NCT02041702

Accent Cardiac MRI Study

A Clinical Evaluation of the Safety and Efficacy of St. Jude Medical (SJM) Magnetic Resonance Imaging (MRI) Conditional Pacing System in Patients Undergoing Cardiac MRI

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to assess safety and efficacy of SJM MRI conditional pacing system. The study hypothesized that cardiac MRI scan would not affect performance of SJM MRI conditional pacing system.

Detailed description

Accent Cardiac MRI study was a prospective, randomized ,multi-center study conducted in Asia. Subjects indicated for dual-chamber pacemaker and who signed study consent form were considered enrolled and post implant were randomized to either Cardiac MRI Scan Group or Control Group. Clinical evaluation and device interrogation were performed at baseline, pre- and post-MRI scan, and one month post-MRI for all subjects. At 9-12 weeks post-implant, patients in Cardiac MRI Scan Group underwent an elective non-diagnostic cardiac MRI scan at 1.5 Tesla (T) while patients in Control group underwent device interrogation and clinical evaluation twice with a 45-minute waiting period in between. The safety endpoint was freedom from MRI-related complications while efficacy endpoint was change in right atrial/ ventricular (RA/RV) capture threshold and sensing amplitude from pre-MRI scan to one month post-MRI scan.

Conditions

• Bradycardia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Non-Diagnostic Cardiac MRI scan

Timeline

• Start date: 2014-06-09
• Primary completion: 2016-03-17
• Completion: 2016-03-17
• First posted: 2014-01-22
• Last updated: 2019-08-21
• Results posted: 2019-08-21

Locations

13 sites across 5 countries: China, Hong Kong, India, Malaysia, Thailand

Regulatory

• FDA-regulated device study