Accent Cardiac MRI Study

Bradycardia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041702
• Other study ID #: CR-13-031-AP-LV
• Status: Completed
• Phase: N/A
• Start date: June 9, 2014
• Est. completion date: March 17, 2016

Study information

• Verified date: August 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: March 17, 2016
• Est. primary completion date: March 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia

Intervention

Diagnostic Test:
• Non-Diagnostic Cardiac MRI scan

Locations

Country	Name	City	State
China	Zhejiang Greentown Cardiovascular Disease Hospital	Hangzhou
Hong Kong	Prince of Wales Hospital	Hong Kong
India	Care Institute of Medical Sciences	Ahmedabad
India	Apollo Hospitals, Bhubaneshwar	Bhubaneshwar
India	Medanta - The Medicity Hospital	Gurgaon
India	Fortis Hospital	Mohali	Punjab
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
Malaysia	Serdang Hospital	Kajang
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

China,  Hong Kong,  India,  Malaysia,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom From MRI Scan-related Complications	Number of subjects who were free from MRI scan-related complications	MRI Visit ,1 Month Post MRI Visit
Primary	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
Primary	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
Primary	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
Primary	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