Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
NCT ID: NCT01576016
Last Updated: 2020-11-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
950 participants
INTERVENTIONAL
2012-03-30
2018-02-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lead Safety
Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead
Accent MRI system (lead safety)
Patients implanted with an Accent MRI system
Accent MRI system MRI Scan Group
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
Accent MRI system (with MRI scan)
Patients implanted with an Accent MRI system will receive an MRI scan
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Accent MRI system (lead safety)
Patients implanted with an Accent MRI system
Accent MRI system (with MRI scan)
Patients implanted with an Accent MRI system will receive an MRI scan
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
13. Are unable to comply with the follow up schedule
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Medical Devices
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Grant Kim
Role: STUDY_DIRECTOR
Abbott Medical Devices
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Glendale Adventist Medical Center
Glendale, California, United States
Scripps Green Hospital
La Jolla, California, United States
Memorial Medical Center
Modesto, California, United States
Premier Cardiology, Inc / Hoag Hospital
Newport Beach, California, United States
Desert Cardiology Consultants
Rancho Mirage, California, United States
Mercy General Hospital
Sacramento, California, United States
Sutter Memorial Hospital
Sacramento, California, United States
Aurora Denver Cardiology Associates
Denver, Colorado, United States
South Denver Cardiology Associates PC
Littleton, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Medical Specialists of the Palm Beaches
Atlantis, Florida, United States
Watson Clinic Center
Lakeland, Florida, United States
Florida Hospital Orlando
Orlando, Florida, United States
Orlando Health
Orlando, Florida, United States
Brevard Cardiovascular Research Associates
Rockledge, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
University of South Florida, Cardiovascular Services
Tampa, Florida, United States
Athens Cardiology Group, PC
Athens, Georgia, United States
Atlanta Heart Specialist
Atlanta, Georgia, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Spectrum Health
Grand Rapids, Michigan, United States
Thoracic Cardio Healthcare Foundation
Lansing, Michigan, United States
Providence Hospital
Southfield, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Alegent Creighton Health
Omaha, Nebraska, United States
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Mid Carolina Cardiology
Charlotte, North Carolina, United States
Wake Forest University Medical Center Clinical Sciences
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Columbus Cardiovascular Associates
Columbus, Ohio, United States
EMH Regional Medical Center
Elyria, Ohio, United States
St. Elizabeth Health Center
Youngstown, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, United States
Abington Medical Specialists
Abington, Pennsylvania, United States
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, United States
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
PMG Research of Charleston, LLC
Charleston, South Carolina, United States
Austin Heart
Austin, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Virginia Cardiovascular Associates, PC
Manassas, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Kitsap Cardiology Consultants
Bremerton, Washington, United States
The Heart Institute at Virginia Mason
Seattle, Washington, United States
Aurora Medical Group
Milwaukee, Wisconsin, 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
Diakonessenhuis Utrecht
Utrecht, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
60028820
Identifier Type: -
Identifier Source: org_study_id