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Accent Cardiac MRI Study (Accent Cardiac)

Primary Purpose

Bradycardia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Non-Diagnostic Cardiac MRI scan
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bradycardia focused on measuring Bradycardia, MRI Conditional Pacemaker, St Jude Medical, Accent MRI Pacemaker, Tendril MRI Lead

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhejiang Greentown Cardiovascular Disease Hospital
  • Prince of Wales Hospital
  • Fortis Hospital
  • Care Institute of Medical Sciences
  • Apollo Hospitals, Bhubaneshwar
  • Medanta - The Medicity Hospital
  • All India Institute of Medical Sciences, New Delhi
  • Fortis Escorts Heart Institute and Research Center
  • Fortis Flt. Lt. Rajan Dhall Hospital
  • Serdang Hospital
  • King Chulalongkorn Memorial Hospital
  • Ramathibodi Hospital
  • Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cardiac MRI Scan Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Freedom From MRI Scan-related Complications
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
December 20, 2013
Last Updated
August 6, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02041702
Brief Title
Accent Cardiac MRI Study
Acronym
Accent Cardiac
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 9, 2014 (Actual)
Primary Completion Date
March 17, 2016 (Actual)
Study Completion Date
March 17, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia
Keywords
Bradycardia, MRI Conditional Pacemaker, St Jude Medical, Accent MRI Pacemaker, Tendril MRI Lead

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two groups in parallel for the duration of the study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
283 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac MRI Scan Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
Non-Diagnostic Cardiac MRI scan
Primary Outcome Measure Information:
Title
Freedom From MRI Scan-related Complications
Description
Number of subjects who were free from MRI scan-related complications
Time Frame
MRI Visit ,1 Month Post MRI Visit
Title
Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan
Description
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
Time Frame
MRI Visit ,1 Month Post MRI Visit
Title
Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan
Description
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
Time Frame
MRI Visit, 1 Month Post MRI Visit
Title
Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
Description
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
Time Frame
MRI Visit, 1 Month Post MRI Visit
Title
Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
Description
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
Time Frame
MRI Visit, 1 Month Post MRI Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Keong Ching, Dr
Organizational Affiliation
National Heart Center Singapore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rabindra Nath Chakraborty, Dr
Organizational Affiliation
Apollo Gleneagles Hospital Kolkata India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Greentown Cardiovascular Disease Hospital
City
Hangzhou
Country
China
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Fortis Hospital
City
Mohali
State/Province
Punjab
Country
India
Facility Name
Care Institute of Medical Sciences
City
Ahmedabad
Country
India
Facility Name
Apollo Hospitals, Bhubaneshwar
City
Bhubaneshwar
Country
India
Facility Name
Medanta - The Medicity Hospital
City
Gurgaon
Country
India
Facility Name
All India Institute of Medical Sciences, New Delhi
City
New Delhi
Country
India
Facility Name
Fortis Escorts Heart Institute and Research Center
City
New Delhi
Country
India
Facility Name
Fortis Flt. Lt. Rajan Dhall Hospital
City
New Delhi
Country
India
Facility Name
Serdang Hospital
City
Kajang
Country
Malaysia
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Accent Cardiac MRI Study

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