Safety and Efficacy of the Accent Magnetic Resonance Imagingâ„¢ (MRI) Pacemaker and Tendril MRIâ„¢ Lead (NCT01576016) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of the Accent Magnetic Resonance Imagingâ„¢ (MRI) Pacemaker and Tendril MRIâ„¢ Lead
United States950 participantsStarted 2012-03-30
Plain-language summary
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRIâ„¢ System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.
Who can participate
SexALL
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Inclusion criteria
✓. 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)
Exclusion criteria
✕. 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
What they're measuring
1
Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
Timeframe: Implant through 2 months
2
Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period
Timeframe: Implant through 2 months
3
Freedom From RA Related Complications in the Chronic Period
Timeframe: 2 months through 12 months
4
Freedom From Right Ventricular Lead Related Complications in the Chronic Period
Timeframe: 2 months through 12 months
5
Freedom From MRI Scan-related Complications
Timeframe: MRI Scan visit through 1 month after MRI scan visit
6
Change in Atrial Capture Threshold From Pre to Post MRI Scan
Timeframe: MRI Scan visit to 1 month after MRI scan visit
7
Change in Ventricular Capture Threshold Pre to Post MRI Scan
Timeframe: MRI Scan visit to 1 month after MRI scan visit