Clinical trial NCT02041702: Accent Cardiac MRI Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Keywords: Bradycardia
MRI Conditional Pacemaker
St Jude Medical
Accent MRI Pacemaker
Tendril MRI Lead
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-01-22
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Freedom From MRI Scan-related Complications
timeFrame: MRI Visit ,1 Month Post MRI Visit
measure: Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan
timeFrame: MRI Visit ,1 Month Post MRI Visit
measure: Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan
timeFrame: MRI Visit, 1 Month Post MRI Visit
measure: Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
timeFrame: MRI Visit, 1 Month Post MRI Visit
measure: Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
timeFrame: MRI Visit, 1 Month Post MRI Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Greentown Cardiovascular Disease Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Mohali
country: India
facility: Fortis Hospital
state: Punjab
city: Ahmedabad
country: India
facility: Care Institute of Medical Sciences
city: Bhubaneshwar
country: India
facility: Apollo Hospitals, Bhubaneshwar
city: Gurgaon
country: India
facility: Medanta - The Medicity Hospital
city: New Delhi
country: India
facility: All India Institute of Medical Sciences, New Delhi
city: New Delhi
country: India
facility: Fortis Escorts Heart Institute and Research Center
city: New Delhi
country: India
facility: Fortis Flt. Lt. Rajan Dhall Hospital
city: Kajang
country: Malaysia
facility: Serdang Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: National Heart Center Singapore
name: Chi Keong Ching, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Apollo Gleneagles Hospital Kolkata India
name: Rabindra Nath Chakraborty, Dr
role: PRINCIPAL_INVESTIGATOR
References: