Overview

This trial is active, not recruiting.

Conditions adverse effect of mri on an implanted pacemaker lead, adverse effect of mri on an implanted pacemaker
Treatments accent mri system
Sponsor St. Jude Medical
Start date March 2012
End date October 2014
Trial size 800 participants
Trial identifier NCT01576016, 60028820

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patient implanted with an Accent MRI system will receive an MRI scan
accent mri system Accent MRI pacemaker
Patients implanted with an Accent MRI system will receive 30 minutes of magnetic scan imaging
(Placebo Comparator)
Patient implanted with an Accent MRI system will not receive an MRI scan
accent mri system Accent MRI pacemaker
Patients implanted with an Accent MRI system will wait for one hour without receiving an MRI scan

Primary Outcomes

Measure
Freedom from right atrial (RA) lead-related complications in the acute period
time frame: Implant through 2 months
Freedom from right ventricular (RV) lead-related complications in the acute time period
time frame: Implant through 2 months
Freedom from RA related complications in the chronic period
time frame: 2 months thru 12 months
Freedom from right ventricular lead related complications in the chronic period
time frame: 2 months thru 12 months
Freedom from MRI scan-related complications
time frame: MRI Scan visit and 1 month after MRI scan visit
Change in atrial capture thresholds (before and after the MRI Scan)
time frame: MRI Scan visit and 1 month after MRI scan visit
Change in ventricular capture thresholds (before and after the MRI scan)
time frame: MRI Scan visit and 1 month after MRI scan visit
Change in atrial sensing threshold (before and after the MRI scan)
time frame: MRI Scan visit and 1 month after MRI scan visit
Change in ventricular sensing threshold (before and after the MRI scan)
time frame: MRI Scan visit and 1 month after the MRI Scan visit

Secondary Outcomes

Measure
Freedom from system-related complications
time frame: Implant through 12 months
Atrial capture threshold at the MRI visit
time frame: MRI Scan visit (approx 3 months post implant)
Ventricular capture threshold at the MRI visit
time frame: MRI Scan visit (approx 3 months post implant)

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: Eligible patients will meet all of the following: 1. Have an approved indication per American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for implantation of a pacemaker 2. Will receive a new pacemaker and lead 3. Be willing to undergo an elective MRI scan without sedation 4. Be able to provide informed consent for study participation (legal guardian is NOT acceptable) 5. Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations 6. Is not contraindicated for an MRI scan (per the pre-MRI safety screening form) Exclusion Criteria: Patients will be excluded if they meet any of the following: 1. Are medically indicated for an MRI scan at the time of enrollment 2. Have an existing pacemaker or implantable cardioverter defibrillator (ICD). A new pacemaker and lead is required for enrollment 3. Have an existing active/inactive implanted medical device, e.g., neurostimulator, infusion pump, etc. 4. Have a non-MRI compatible device or material implanted (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.) 5. Have a lead extender or adaptor 6. Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore. 7. Have a prosthetic tricuspid heart valve 8. Are currently participating in a clinical investigation that includes an active treatment arm 9. Are allergic to dexamethasone sodium phosphate (DSP) 10. Are pregnant or planning to become pregnant during the duration of the study 11. Have a life expectancy of less than 12 months due to any condition 12. Patients with exclusion criteria required by local law (e.g., age) 13. Are unable to comply with the follow up schedule

Additional Information

Official title Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study
Description The safety and efficacy of the Accent MRI pacemaker and Tendril MRI lead will be evaluated as described below: Lead Safety Safety of the Tendril MRI™ lead will be evaluated in terms of freedom from RA and RV lead-related complications at implant to 2 months, and at the 2 through the 12 month visit. MRI Safety The safety of the Accent MRI™ system will be evaluated in terms of freedom from MRI scan related complications in the month following the MRI scan. Lead Efficacy Efficacy of the Tendril MRI™ lead will be evaluated in terms of the change in atrial and ventricular capture and sensing thresholds before and after the MRI scan. Secondary Endpoints Safety Safety of the Accent MRI™ system will be evaluated in terms of freedom from system-related complications through the 12 month visit. Efficacy Efficacy of the Tendril MRI™ lead will be evaluated in terms of the atrial and ventricular capture thresholds at the MRI Visit.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.