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 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
950
Patients implanted with an Accent MRI system
Patients implanted with an Accent MRI system will receive an MRI scan
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 .
Time frame: 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.
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University Hospital of Alabama at Birmingham
Birmingham, Alabama, United States
Heart Center Research
Huntsville, Alabama, United States
Arizona Arrhythmia Research Center
Phoenix, Arizona, United States
Baptist Health Medical Center
Little Rock, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Mercy Hospital Northwest Arkansas
Rogers, Arkansas, United States
Central Cardiology
Bakersfield, California, United States
Raymond Schaerf, MD
Burbank, California, United States
John Muir Medical Center
Concord, California, United States
St. Jude Hospital
Fullerton, California, United States
...and 60 more locations
Time frame: 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.
Time frame: 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.
Time frame: MRI Scan visit to 1 month after the MRI Scan visit
Freedom From System-related Complications
Percentage of patients who do not have system-related complications from implant through the 12 month study visit
Time frame: 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
Time frame: 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
Time frame: MRI Scan visit (approx 3 months post implant)