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Trial record 2 of 3 for:    Accent MRI™ Pacemaker

Accent Cardiac MRI Study (Accent Cardiac)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02041702
Recruitment Status : Completed
First Posted : January 22, 2014
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE December 20, 2013
First Posted Date  ICMJE January 22, 2014
Results First Submitted Date  ICMJE August 18, 2017
Results First Posted Date  ICMJE August 21, 2019
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE June 9, 2014
Actual Primary Completion Date March 17, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Freedom From MRI Scan-related Complications [ Time Frame: MRI Visit ,1 Month Post MRI Visit ]
    Number of subjects who were free from MRI scan-related complications
  • Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan [ Time Frame: MRI Visit ,1 Month Post MRI Visit ]
    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
  • Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan [ Time Frame: MRI Visit, 1 Month Post MRI Visit ]
    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
  • Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan [ Time Frame: MRI Visit, 1 Month Post MRI Visit ]
    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
  • Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan [ Time Frame: MRI Visit, 1 Month Post MRI Visit ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2014)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accent Cardiac MRI Study
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Provided
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are assigned to one of two groups in parallel for the duration of the study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Bradycardia
Intervention  ICMJE Diagnostic Test: Non-Diagnostic Cardiac MRI scan
Study Arms  ICMJE
  • Experimental: Cardiac MRI Scan Group
    Intervention: Diagnostic Test: Non-Diagnostic Cardiac MRI scan
  • No Intervention: Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2016)
283
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2014)
252
Actual Study Completion Date  ICMJE March 17, 2016
Actual Primary Completion Date March 17, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Hong Kong,   India,   Malaysia,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02041702
Other Study ID Numbers  ICMJE CR-13-031-AP-LV
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Abbott Medical Devices
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP