Accent Cardiac MRI Study (Accent Cardiac)

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

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.

Study Overview

• Status: Completed
• Conditions: Bradycardia
• Intervention / Treatment: Diagnostic test: Non-Diagnostic Cardiac MRI scan

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.

• Study Type: Interventional
• Enrollment (Actual): 283
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • Zhejiang Greentown Cardiovascular Disease Hospital
• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
• India
  • Ahmedabad, India
    • Care Institute of Medical Sciences
  • Bhubaneshwar, India
    • Apollo Hospitals, Bhubaneshwar
  • Gurgaon, India
    • Medanta - The Medicity Hospital
  • New Delhi, India
    • All India Institute of Medical Sciences, New Delhi
  • New Delhi, India
    • Fortis Escorts Heart Institute and Research Center
  • New Delhi, India
    • Fortis Flt. Lt. Rajan Dhall Hospital
  • Punjab
    • Mohali, Punjab, India
      • Fortis Hospital
• Malaysia
  • Kajang, Malaysia
    • Serdang Hospital
• Thailand
  • Bangkok, Thailand
    • Siriraj Hospital
  • Bangkok, Thailand
    • Ramathibodi Hospital
  • Bangkok, Thailand
    • King Chulalongkorn Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Have an approved indication per American College of Cardiology(ACC)/ American Heart Association(AHA)/ Heart Rhythm Society(HRS)/ European Society of Cardiology(ESC) guidelines for implantation of a pacemaker
• Will receive a new dual chamber pacemaker and leads
• Be willing to undergo an elective MRI scan without complete sedation, that is ,under consciousness during MRI scan
• Be able to provide informed consent for study participation
• Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
• Is not contraindicated for an MRI scan (per the pre-MRI safety screening form)
• Age≥18 years
• Subjects must be able to undergo pectoral implantation

Exclusion Criteria

• Having an existing pacemaker or Implantable Cardioverter Defibrillator (ICD) .A new pacemaker and lead is required for enrollment
• Permanent Atrial Fibrillation/Flutter
• Are medically indicated for an MRI scan at the time of enrollment
• Have an existing active implanted medical device, e.g. neurostimulator, infusion pump etc
• Have a non-MRI compatible device or material implanted
• Have a lead extender or adaptor
• Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore
• Are currently participating in a clinical investigation that includes an active treatment arm
• Are allergic to dexamethasone sodium phosphate(DSP)
• Are pregnant or planning to become pregnant during the duration of the study
• Have a life expectancy of less than 12 months due to any condition
• Subjects with exclusion criteria required by local law (e.g. age)
• Are unable to comply with the follow up schedule

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Cardiac MRI Scan Group	Diagnostic test: Non-Diagnostic Cardiac MRI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom From MRI Scan-related Complications	Number of subjects who were free from MRI scan-related complications	MRI Visit ,1 Month Post MRI Visit
Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan	Number of subjects who experienced an increase in RA capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 Volt (V) compared to pre-MRI scan value collected at MRI scan visit	MRI Visit ,1 Month Post MRI Visit
Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan	Number of subjects who experienced an increase in RV capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 V compared to pre-MRI scan value collected at MRI scan visit	MRI Visit, 1 Month Post MRI Visit
Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan	Number of subjects who experienced a decrease in RA sensing amplitude ≤ 50% and at least 1.5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit	MRI Visit, 1 Month Post MRI Visit
Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan	Number of subjects who experienced a decrease in RV sensing amplitude ≤ 50% and at least 5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit	MRI Visit, 1 Month Post MRI Visit

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Chi Keong Ching, Dr, National Heart Center Singapore; Principal Investigator: Rabindra Nath Chakraborty, Dr, Apollo Gleneagles Hospital Kolkata India

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2014
• Primary Completion (Actual): March 17, 2016
• Study Completion (Actual): March 17, 2016

Study Registration Dates

• First Submitted: December 20, 2013
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Bradycardia; MRI Conditional Pacemaker; St Jude Medical; Accent MRI Pacemaker; Tendril MRI Lead
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: CR-13-031-AP-LV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes