Accent Cardiac MRI Study
- Conditions
- Bradycardia
- Interventions
- Diagnostic Test: Non-Diagnostic Cardiac MRI scan
- Registration Number
- NCT02041702
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 283
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cardiac MRI Scan Group Non-Diagnostic Cardiac MRI scan -
- Primary Outcome Measures
Name Time Method Freedom From MRI Scan-related Complications 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Medanta - The Medicity Hospital
🇮🇳Gurgaon, India
Serdang Hospital
🇲🇾Kajang, Malaysia
Siriraj Hospital
🇹🇭Bangkok, Thailand
Care Institute of Medical Sciences
🇮🇳Ahmedabad, India
Apollo Hospitals, Bhubaneshwar
🇮🇳Bhubaneshwar, India
Fortis Flt. Lt. Rajan Dhall Hospital
🇮🇳New Delhi, 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
King Chulalongkorn Memorial Hospital
🇹🇭Bangkok, Thailand
Ramathibodi Hospital
🇹🇭Bangkok, Thailand
Zhejiang Greentown Cardiovascular Disease Hospital
🇨🇳Hangzhou, China
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong