N/A
Completed N=920
Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
Adverse Effect of MRI on an Implanted Pacemaker Lead · Adverse Effect of MRI on an Implanted Pacemaker
Source: ClinicalTrials.gov NCT01576016 ↗
Enrolled (actual)
920
Serious AEs
6.0%
Results posted
Nov 2020
Primary outcomePrimary: Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period — 97.2 percentage of subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period |
97.2 | — |
| PRIMARY Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period |
98.45 | — |
| PRIMARY Freedom From RA Related Complications in the Chronic Period |
98.82 | — |
| PRIMARY Freedom From Right Ventricular Lead Related Complications in the Chronic Period |
100 | — |
| PRIMARY Freedom From MRI Scan-related Complications |
100 | — |
| PRIMARY Change in Atrial Capture Threshold From Pre to Post MRI Scan |
100 | — |
| PRIMARY Change in Ventricular Capture Threshold Pre to Post MRI Scan |
100 | — |
| PRIMARY Change in Atrial Sense Amplitude |
92.56 | — |
| PRIMARY Change in Ventricular Sense Amplitude |
97.76 | — |
| SECONDARY Freedom From System-related Complications |
94.64 | — |
| SECONDARY Atrial Capture Threshold at the MRI Visit |
100.00 | — |
| SECONDARY Ventricular Capture Threshold at the MRI Visit |
100.00 | — |
Eligibility Criteria
Inclusion Criteria
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)
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT01576016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.