Clinical Trial: Accent Cardiac MRI Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Clinical Evaluation of the Safety and Efficacy of SJM MRI Conditional Pacing System in Patients Undergoing Cardiac Magnetic Resonance Imaging (Conducted Under the Protocol Title "A Clinical Eva

Brief Summary: The aim of this study is to assess the safety and efficacy of the SJM MRI conditional pacing system in subjects undergoing Cardiac Magnetic Resonance Imaging.The study hypothesis is that cardiac MRI scan will not affect the performance of the SJM MRI conditional pacing system when special conditions are met. Comparing with the control group,freedom from MRI scan-related complications and the electronic performances such as pacing threshold,sensing amplitude should be similar.

Detailed Summary:

The purpose of this study is to evaluate the safety and efficacy of SJM MRI conditional pacing system during and after Cardiac Magnetic Resonance Imaging (MRI) Scan. The SJM MRI conditional pacing system consists of a SJM MRI conditional pacemaker and leads. It is conditionally safe for use in the MRI environment.The study will be conducted in Asian regions/countries.

Accent Cardiac MRI study is a prospective,randomized ,multi center study .After signing the consent form ,patients will be enrolled in this study. Total subjects number will be 252 .These patients will be randomized into 2 groups: 126 patients will be randomized into the MRI scan group and 126 patients will be randomized into the control group. The study will last 2.5 years .Individual patient participation in the study will last approximately 4 to 5 months.

All patients who decide to participate in the study will be implanted with the Accent MRI ™ dual chamber pacemaker and Tendril MRI™ leads or other commercially available new SJM MRI conditional pacing system. After implant, before the MRI visit, patients will be randomized to either MRI Scan Group or Control Group in a 1:1 ratio. Patients in MRI Scan Group will undergo an MRI scan at the MRI visit (9~12 weeks after implant) while patients in Control Group will not receive an MRI scan in that visit. After MRI scan ,the patient's pacing system will be examined with a programmer to assess whether there are any changes in electronic parameters such as pacing capture threshold,sensing amplitude as well as lead impedence . 1 month after the MRI visit , all patients will come back to hospital to have another study follow up including physical examination and device interrogation .


Sponsor: St. Jude Medical

Current Primary Outcome:

  • Freedom from MRI scan-related complications [ Time Frame: MRI Visit ,1 Month Post MRI Visit ]
  • Change in right atrial/ventricular capture threshold @0.5ms before and 1 month after the MRI scan [ Time Frame: MRI Visit ,1 Month Post MRI Visit ]
  • Change in right atrial/ventricular sensing amplitude before and 1 month after the MRI scan [ Time Frame: MRI Visit, 1 Month Post MRI Visit ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Jude Medical

Dates:
Date Received: December 20, 2013
Date Started: June 2014
Date Completion:
Last Updated: July 17, 2016
Last Verified: July 2016