NCT01576016

Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead

Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 950 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.

Detailed description

The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment. The study consisted of two phases, a Lead Safety Phase which evaluated the safety of the Tendril MRI lead, and an MRI Phase which evaluated the safety and efficacy of the Accent MRI pacemaker system in an MRI environment. The safety and efficacy of the Accent MRI pacemaker and Tendril MRI lead will be evaluated as described below: Lead Safety Safety of the Tendril MRI™ lead will be evaluated in terms of freedom from right atrial (RA) and right ventricle (RV) lead-related complications at implant to 2 months (acute timeframe), and at the 2 through the 12 month visit (chronic timeframe). MRI Safety The safety of the Accent MRI™ system will be evaluated in terms of freedom from MRI scan related complications in the month following the MRI scan. Lead Efficacy Efficacy of the Tendril MRI™ lead will be evaluated in terms of the change in atrial and ventricular capture and sensing thresholds before and after the MRI scan. MRI Efficacy Efficacy of the Tendril MR lead will be evaluated in terms of the change in bipolar atrial and ventricular capture and sensing thresholds before and after the MRI scan. Secondary Endpoints Safety Safety of the Accent MRI™ system will be evaluated in terms of freedom from system-related complications through the 12 month visit. Efficacy Efficacy of the Tendril MRI™ lead will be evaluated in terms of the atrial and ventricular capture thresholds at the MRI Visit.

Conditions

• Adverse Effect of MRI on an Implanted Pacemaker Lead
• Adverse Effect of MRI on an Implanted Pacemaker

Interventions

Type	Name	Description
DEVICE	Accent MRI system (lead safety)	Patients implanted with an Accent MRI system
DEVICE	Accent MRI system (with MRI scan)	Patients implanted with an Accent MRI system will receive an MRI scan

Timeline

• Start date: 2012-03-30
• Primary completion: 2018-02-02
• Completion: 2018-02-02
• First posted: 2012-04-12
• Last updated: 2020-11-10
• Results posted: 2020-11-10

Locations

70 sites across 5 countries: United States, Australia, Belgium, Finland, Netherlands