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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The study consisted of two phases, a Lead Safety Phase which evaluated the safety of the Tendril MRI lead, and an MRI Phase which evaluated the safety and efficacy of the Accent MRI pacemaker system in an MRI environment. 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 right atrial (RA) and right ventricle (RV) lead-related complications at implant to 2 months (acute timeframe), and at the 2 through the 12 month visit (chronic timeframe). 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. MRI Efficacy Efficacy of the Tendril MR lead will be evaluated in terms of the change in bipolar 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.

Official Title
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Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study

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

Intervention / Treatment
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* Device: Accent MRI system (lead safety)
* Device: Accent MRI system (with MRI scan)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lead Safety<br>Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead | Device: Accent MRI system (lead safety)<br>* Patients implanted with an Accent MRI system<br>* Other names: Tendril MRI lead;|
| Experimental: Accent MRI system MRI Scan Group<br>Patient implanted with an Accent MRI system will receive an MRI scan to evaluate safety and efficacy of the Accent MRI system in an MRI environment | Device: Accent MRI system (with MRI scan)<br>* Patients implanted with an Accent MRI system will receive an MRI scan<br>* Other names: Tendril MRI lead;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period | Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit | Implant through 2 months | 
| Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period | Percentage of patients who do not have RV lead-related complications from implant through the 2 month study visit | Implant through 2 months | 
| Freedom From RA Related Complications in the Chronic Period | Percentage of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit | 2 months through 12 months | 
| Freedom From Right Ventricular Lead Related Complications in the Chronic Period | Percentage of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit | 2 months through 12 months | 
| Freedom From MRI Scan-related Complications | Percentage of patients who do not have MRI-related complications from the MRI scan visit to the 1 month post MRI scan visit | MRI Scan visit through 1 month after MRI scan visit | 
| Change in Atrial Capture Threshold From Pre to Post MRI Scan | Percentage of patients with an increase in RA capture thresholds of <= 0.5 V, at a pulse width of 0.5 ms . | MRI Scan visit to 1 month after MRI scan visit | 
| Change in Ventricular Capture Threshold Pre to Post MRI Scan | Percentage of patients with an increase in RV capture thresholds of <=0.5V, at a pulse width of 0.5 ms. | MRI Scan visit to 1 month after MRI scan visit | 
| Change in Atrial Sense Amplitude | Percentage of patients with a reduction in RA sense amplitude <=50 % and sense amplitude >=1.5 mV. | MRI Scan visit to 1 month after MRI scan visit | 
| Change in Ventricular Sense Amplitude | Percentage of patients with an reduction in RV sense amplitude <=50% and sense amplitude >=5 mV. | MRI Scan visit to 1 month after the MRI Scan visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From System-related Complications | Percentage of patients who do not have system-related complications from implant through the 12 month study visit | Implant through 12 months | 
| Atrial Capture Threshold at the MRI Visit | Percentage of patients with RA capture threshold ≤2.0 volts (V) at the MRI visit | MRI Scan visit (approx 3 months post implant) | 
| Ventricular Capture Threshold at the MRI Visit | Percentage of patients with RV capture threshold ≤2.0 V at the MRI visit | MRI Scan visit (approx 3 months post implant) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bradycardia, MRI scans