Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
- Conditions
- Adverse Effect of MRI on an Implanted PacemakerAdverse Effect of MRI on an Implanted Pacemaker Lead
- Interventions
- Device: Accent MRI system (lead safety)Device: Accent MRI system (with MRI scan)
- Registration Number
- NCT01576016
- Lead Sponsor
- Abbott Medical Devices
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 950
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)
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lead Safety Accent MRI system (lead safety) Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead Accent MRI system MRI Scan Group Accent MRI system (with MRI scan) 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
- Primary Outcome Measures
Name Time Method Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period 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 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 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 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 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 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 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 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 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 Outcome Measures
Name Time Method Ventricular Capture Threshold at the MRI Visit MRI Scan visit (approx 3 months post implant) Percentage of patients with RV capture threshold ≤2.0 V at the MRI visit
Freedom From System-related Complications Implant through 12 months Percentage of patients who do not have system-related complications from implant through the 12 month study visit
Atrial Capture Threshold at the MRI Visit MRI Scan visit (approx 3 months post implant) Percentage of patients with RA capture threshold ≤2.0 volts (V) at the MRI visit
Trial Locations
- Locations (70)
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
Premier Cardiology, Inc / Hoag Hospital
🇺🇸Newport Beach, California, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Memorial Medical Center
🇺🇸Modesto, California, United States
South Denver Cardiology Associates PC
🇺🇸Littleton, Colorado, United States
Medical Specialists of the Palm Beaches
🇺🇸Atlantis, Florida, United States
Medical Center of the Rockies
🇺🇸Loveland, Colorado, United States
Watson Clinic Center
🇺🇸Lakeland, Florida, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Heart Center Research
🇺🇸Huntsville, Alabama, United States
Mercy Hospital Northwest Arkansas
🇺🇸Rogers, Arkansas, United States
Central Cardiology
🇺🇸Bakersfield, California, United States
Raymond Schaerf, MD
🇺🇸Burbank, California, United States
St. Jude Hospital
🇺🇸Fullerton, California, United States
Mid Carolina Cardiology
🇺🇸Charlotte, North Carolina, United States
EMH Regional Medical Center
🇺🇸Elyria, Ohio, United States
Oklahoma Heart Institute at Utica
🇺🇸Tulsa, Oklahoma, United States
Abington Medical Specialists
🇺🇸Abington, Pennsylvania, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Virginia Cardiovascular Associates, PC
🇺🇸Manassas, Virginia, United States
Kitsap Cardiology Consultants
🇺🇸Bremerton, Washington, United States
St. Andrews Hospital
🇦🇺Adelaide, South Australia, Australia
Cliniques Universitaires Saint Luc
🇧🇪Brussels, B Cap R, Belgium
Kuopio University Hospital
🇫🇮Kuopio, East Finland, Finland
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Donald Guthrie Foundation for Education and Research
🇺🇸Sayre, Pennsylvania, United States
South Texas Cardiovascular Consultants
🇺🇸San Antonio, Texas, United States
The Heart Institute at Virginia Mason
🇺🇸Seattle, Washington, United States
Desert Cardiology Consultants
🇺🇸Rancho Mirage, California, United States
Aurora Denver Cardiology Associates
🇺🇸Denver, Colorado, United States
Atlanta Heart Specialist
🇺🇸Atlanta, Georgia, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Columbus Cardiovascular Associates
🇺🇸Columbus, Ohio, United States
St. Elizabeth Health Center
🇺🇸Youngstown, Ohio, United States
University Hospital of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Arizona Arrhythmia Research Center
🇺🇸Phoenix, Arizona, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Allegheny Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
John Muir Medical Center
🇺🇸Concord, California, United States
Diakonessenhuis Utrecht
🇳🇱Utrecht, Netherlands
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Baptist Health Medical Center
🇺🇸Little Rock, Arkansas, United States
York Hospital
🇺🇸York, Pennsylvania, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
Alegent Creighton Health
🇺🇸Omaha, Nebraska, United States
Aurora Medical Group
🇺🇸Milwaukee, Wisconsin, United States
Brevard Cardiovascular Research Associates
🇺🇸Rockledge, Florida, United States
Athens Cardiology Group, PC
🇺🇸Athens, Georgia, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States
Thoracic Cardio Healthcare Foundation
🇺🇸Lansing, Michigan, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
Sutter Memorial Hospital
🇺🇸Sacramento, California, United States
Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
Orlando Health
🇺🇸Orlando, Florida, United States
University of South Florida, Cardiovascular Services
🇺🇸Tampa, Florida, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
PMG Research of Charleston, LLC
🇺🇸Charleston, South Carolina, United States
Wake Forest University Medical Center Clinical Sciences
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Austin Heart
🇺🇸Austin, Texas, United States
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States