Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead

Completed · Not applicable

Conditions studied: Adverse Effect of MRI on an Implanted Pacemaker Lead, Adverse Effect of MRI on an Implanted Pacemaker

In brief

The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.

Key facts

Study ID

NCT01576016

Run by

Abbott Medical Devices

People needed

950

Starts

2012-03-30

Expected to finish

2018-02-02

Last updated by the study team

2020-11-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible patients will meet all of the following:
• Have an approved indication per American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for implantation of a pacemaker
• Will receive a new pacemaker and lead
• Be willing to undergo an elective MRI scan without sedation
• Be able to provide informed consent for study participation (legal guardian is NOT acceptable)
• 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)

You may not qualify if…

• Patients will be excluded if they meet any of the following:
• Are medically indicated for an MRI scan at the time of enrollment
• Have an existing pacemaker or implantable cardioverter defibrillator (ICD). A new pacemaker and lead is required for enrollment
• Have an existing active/inactive implanted medical device, e.g., neurostimulator, infusion pump, etc.
• Have a non-MRI compatible device or material implanted (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.)
• 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.
• Have a prosthetic tricuspid heart valve
• 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
• Patients with exclusion criteria required by local law (e.g., age)
• Are unable to comply with the follow up schedule

Where it is running

• Heart Center Research — Huntsville, Alabama, United States
• Arizona Arrhythmia Research Center — Phoenix, Arizona, United States
• Baptist Health Medical Center — Little Rock, Arkansas, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Mercy Hospital Northwest Arkansas — Rogers, Arkansas, United States
• Central Cardiology — Bakersfield, California, United States
• Raymond Schaerf, MD — Burbank, California, United States
• John Muir Medical Center — Concord, California, United States
• St. Jude Hospital — Fullerton, California, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• Scripps Green Hospital — La Jolla, California, United States
• Memorial Medical Center — Modesto, California, United States
• Premier Cardiology, Inc / Hoag Hospital — Newport Beach, California, United States
• Desert Cardiology Consultants — Rancho Mirage, California, United States
• Mercy General Hospital — Sacramento, California, United States
• Sutter Memorial Hospital — Sacramento, California, United States
• Aurora Denver Cardiology Associates — Denver, Colorado, United States
• South Denver Cardiology Associates PC — Littleton, Colorado, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Medical Specialists of the Palm Beaches — Atlantis, Florida, United States
• Watson Clinic Center — Lakeland, Florida, United States
• Florida Hospital Orlando — Orlando, Florida, United States
• Orlando Health — Orlando, Florida, United States
• Brevard Cardiovascular Research Associates — Rockledge, Florida, United States
• University Hospital of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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