Adverse Effect of MRI on an Implanted Pacemaker Clinical Trial
Official title:
Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study
| Verified date | October 2020 |
| Source | Abbott Medical Devices |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 950 |
| Est. completion date | February 2, 2018 |
| Est. primary completion date | February 2, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: Eligible patients will meet all of the following: 1. Have an approved indication per American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for implantation of a pacemaker 2. Will receive a new pacemaker and lead 3. Be willing to undergo an elective MRI scan without sedation 4. Be able to provide informed consent for study participation (legal guardian is NOT acceptable) 5. Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations 6. 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: 1. Are medically indicated for an MRI scan at the time of enrollment 2. Have an existing pacemaker or implantable cardioverter defibrillator (ICD). A new pacemaker and lead is required for enrollment 3. Have an existing active/inactive implanted medical device, e.g., neurostimulator, infusion pump, etc. 4. Have a non-MRI compatible device or material implanted (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.) 5. Have a lead extender or adaptor 6. Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore. 7. Have a prosthetic tricuspid heart valve 8. Are currently participating in a clinical investigation that includes an active treatment arm 9. Are allergic to dexamethasone sodium phosphate (DSP) 10. Are pregnant or planning to become pregnant during the duration of the study 11. Have a life expectancy of less than 12 months due to any condition 12. Patients with exclusion criteria required by local law (e.g., age) 13. Are unable to comply with the follow up schedule |
| Country | Name | City | State |
|---|---|---|---|
| Australia | St. Andrews Hospital | Adelaide | South Australia |
| Belgium | Cliniques Universitaires Saint Luc | Brussels | B Cap R |
| Finland | Kuopio University Hospital | Kuopio | East Finland |
| Netherlands | Diakonessenhuis Utrecht | Utrecht | |
| United States | Abington Medical Specialists | Abington | Pennsylvania |
| United States | Athens Cardiology Group, PC | Athens | Georgia |
| United States | Atlanta Heart Specialist | Atlanta | Georgia |
| United States | Medical Specialists of the Palm Beaches | Atlantis | Florida |
| United States | Austin Heart | Austin | Texas |
| United States | Central Cardiology | Bakersfield | California |
| United States | University Hospital of Alabama at Birmingham | Birmingham | Alabama |
| United States | Kitsap Cardiology Consultants | Bremerton | Washington |
| United States | Raymond Schaerf, MD | Burbank | California |
| United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | PMG Research of Charleston, LLC | Charleston | South Carolina |
| United States | Mid Carolina Cardiology | Charlotte | North Carolina |
| United States | Martha Jefferson Hospital | Charlottesville | Virginia |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Columbus Cardiovascular Associates | Columbus | Ohio |
| United States | The Ohio State University | Columbus | Ohio |
| United States | John Muir Medical Center | Concord | California |
| United States | Aurora Denver Cardiology Associates | Denver | Colorado |
| United States | EMH Regional Medical Center | Elyria | Ohio |
| United States | St. Jude Hospital | Fullerton | California |
| United States | Glendale Adventist Medical Center | Glendale | California |
| United States | Spectrum Health | Grand Rapids | Michigan |
| United States | Heart Center Research | Huntsville | Alabama |
| United States | St. Luke's Hospital | Kansas City | Missouri |
| United States | Scripps Green Hospital | La Jolla | California |
| United States | Watson Clinic Center | Lakeland | Florida |
| United States | Thoracic Cardio Healthcare Foundation | Lansing | Michigan |
| United States | Central Baptist Hospital | Lexington | Kentucky |
| United States | Arkansas Heart Hospital | Little Rock | Arkansas |
| United States | Baptist Health Medical Center | Little Rock | Arkansas |
| United States | South Denver Cardiology Associates PC | Littleton | Colorado |
| United States | Medical Center of the Rockies | Loveland | Colorado |
| United States | Virginia Cardiovascular Associates, PC | Manassas | Virginia |
| United States | Aurora Medical Group | Milwaukee | Wisconsin |
| United States | Minneapolis Heart Institute | Minneapolis | Minnesota |
| United States | Memorial Medical Center | Modesto | California |
| United States | Ochsner Medical Center | New Orleans | Louisiana |
| United States | Premier Cardiology, Inc / Hoag Hospital | Newport Beach | California |
| United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
| United States | Integris Baptist Medical Center | Oklahoma City | Oklahoma |
| United States | Alegent Creighton Health | Omaha | Nebraska |
| United States | Florida Hospital Orlando | Orlando | Florida |
| United States | Orlando Health | Orlando | Florida |
| United States | Arizona Arrhythmia Research Center | Phoenix | Arizona |
| United States | Allegheny Singer Research Institute | Pittsburgh | Pennsylvania |
| United States | Desert Cardiology Consultants | Rancho Mirage | California |
| United States | University of Rochester Medical Center | Rochester | New York |
| United States | Brevard Cardiovascular Research Associates | Rockledge | Florida |
| United States | Mercy Hospital Northwest Arkansas | Rogers | Arkansas |
| United States | Mercy General Hospital | Sacramento | California |
| United States | Sutter Memorial Hospital | Sacramento | California |
| United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | South Texas Cardiovascular Consultants | San Antonio | Texas |
| United States | Donald Guthrie Foundation for Education and Research | Sayre | Pennsylvania |
| United States | The Heart Institute at Virginia Mason | Seattle | Washington |
| United States | Providence Hospital | Southfield | Michigan |
| United States | Prairie Education and Research Cooperative | Springfield | Illinois |
| United States | Tallahassee Research Institute | Tallahassee | Florida |
| United States | University of South Florida, Cardiovascular Services | Tampa | Florida |
| United States | Scott & White Memorial Hospital | Temple | Texas |
| United States | Oklahoma Heart Institute at Utica | Tulsa | Oklahoma |
| United States | Wake Forest University Medical Center Clinical Sciences | Winston-Salem | North Carolina |
| United States | York Hospital | York | Pennsylvania |
| United States | St. Elizabeth Health Center | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices |
United States, Australia, Belgium, Finland, Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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) | |
| Secondary | 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) |