Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Adverse Effect of MRI on an Implanted Pacemaker Lead
- Sponsor
- Abbott Medical Devices
- Enrollment
- 950
- Locations
- 70
- Primary Endpoint
- Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
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)
Outcomes
Primary Outcomes
Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period
Time Frame: Implant through 2 months
Percentage of patients who do not have RV lead-related complications from implant through the 2 month study visit
Freedom From MRI Scan-related Complications
Time Frame: MRI Scan visit through 1 month after MRI scan visit
Percentage of patients who do not have MRI-related complications from the MRI scan visit to the 1 month post MRI scan visit
Change in Atrial Capture Threshold From Pre to Post MRI Scan
Time Frame: MRI Scan visit to 1 month after MRI scan visit
Percentage of patients with an increase in RA capture thresholds of \<= 0.5 V, at a pulse width of 0.5 ms .
Change in Ventricular Sense Amplitude
Time Frame: MRI Scan visit to 1 month after the MRI Scan visit
Percentage of patients with an reduction in RV sense amplitude \<=50% and sense amplitude \>=5 mV.
Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
Time Frame: Implant through 2 months
Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit
Freedom From RA Related Complications in the Chronic Period
Time Frame: 2 months through 12 months
Percentage of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit
Freedom From Right Ventricular Lead Related Complications in the Chronic Period
Time Frame: 2 months through 12 months
Percentage of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit
Change in Atrial Sense Amplitude
Time Frame: MRI Scan visit to 1 month after MRI scan visit
Percentage of patients with a reduction in RA sense amplitude \<=50 % and sense amplitude \>=1.5 mV.
Change in Ventricular Capture Threshold Pre to Post MRI Scan
Time Frame: MRI Scan visit to 1 month after MRI scan visit
Percentage of patients with an increase in RV capture thresholds of \<=0.5V, at a pulse width of 0.5 ms.
Secondary Outcomes
- Ventricular Capture Threshold at the MRI Visit(MRI Scan visit (approx 3 months post implant))
- Freedom From System-related Complications(Implant through 12 months)
- Atrial Capture Threshold at the MRI Visit(MRI Scan visit (approx 3 months post implant))