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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

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.

Condition or disease Intervention/treatment Phase
Bradycardia Diagnostic Test: Non-Diagnostic Cardiac MRI scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 participants
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
Official Title: 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
Actual Study Start Date : June 9, 2014
Actual Primary Completion Date : March 17, 2016
Actual Study Completion Date : March 17, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cardiac MRI Scan Group Diagnostic Test: Non-Diagnostic Cardiac MRI scan
No Intervention: Control Group



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041702


Locations
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China
Zhejiang Greentown Cardiovascular Disease Hospital
Hangzhou, China
Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
India
Fortis Hospital
Mohali, Punjab, India
Care Institute of Medical Sciences
Ahmedabad, India
Apollo Hospitals, Bhubaneshwar
Bhubaneshwar, India
Medanta - The Medicity Hospital
Gurgaon, 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
New Delhi, India
Malaysia
Serdang Hospital
Kajang, Malaysia
Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Chi Keong Ching, Dr National Heart Center Singapore
Principal Investigator: Rabindra Nath Chakraborty, Dr Apollo Gleneagles Hospital Kolkata India
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02041702    
Other Study ID Numbers: CR-13-031-AP-LV
First Posted: January 22, 2014    Key Record Dates
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Abbott Medical Devices:
Bradycardia
MRI Conditional Pacemaker
St Jude Medical
Accent MRI Pacemaker
Tendril MRI Lead
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes