ImageReady(TM) MR Conditional Pacing System Clinical Study
NCT ID: NCT01781078
Last Updated: 2019-12-03
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
363 participants
INTERVENTIONAL
2013-02-28
2019-09-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
ENABLE MRI (Magnetic Resonance Imaging)
NCT02652481
INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI
NCT01890512
Registry Study of Clinical Application of MRI Compatible CIED
NCT02380300
Maveric Magnetic Resonance Imaging Used to Study Detailed Bone Apposition and Fixation of the Stryker Trident II Tritanium System
NCT03469817
Study Evaluating the Use of MRI on CMS Patients
NCT02513056
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MRI Group
Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
MRI
The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
ImageReady System implant
Pacemaker and lead(s) implant
Control Group
Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.
ImageReady System implant
Pacemaker and lead(s) implant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MRI
The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
ImageReady System implant
Pacemaker and lead(s) implant
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
* Subject has a Class I or II indication for implantation of a single or dual chamber pacemaker according to the ACC/AHA/HRS, or ESC guidelines, as appropriate per geography
* Subject is able and willing to undergo an MRI scan without intravenous sedation
* Subject is willing and capable of providing informed consent (which can include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
* Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria
* Subject has any MR Unsafe implants or devices with an unknown MR status, including MR Unsafe sternal wires, neurostimulators, biostimulator, metals or alloys, per labeling of each implant
* Subject has any MR Conditional implants or devices that impact the ability to conduct this protocol
* Subject needs or will need another MR scan within 14 weeks of system implant, other than that required by the SAMURAI Study
* Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
* Subject has a mechanical tricuspid heart valve
* Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries\* that are not in conflict and do not affect the following:
* Schedule of procedures for the SAMURAI Study (i.e. should not cause additional or missed visits);
* SAMURAI Study outcome (i.e. involve medications that could affect pacing thresholds);
* Conduct of the SAMURAI Study per GCP/ ISO 14155:2011/ local regulations
* Subjects with documented permanent or persistent AF where the physician intends to implant a dual chamber pulse generator (single chamber VVIR pulse generators are acceptable)
* Subject is currently on the active heart transplant list
* Subject has documented life expectancy of less than 12 months
* Women of childbearing potential who are or might be pregnant at the time of study enrollment or ImageReady MR Conditional Pacing System implant (method of assessment upon physician's discretion)
* Subjects currently requiring dialysis
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Scientific Corporation
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.
Ronald Berger, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Hospital, Carnegie 530, 600 N. Wolfe St, Baltimore, MD 21287
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Banner Heart Hospital
Mesa, Arizona, United States
USC Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Orlando Regional Medical Center
Orlando, Florida, United States
University Community Hospital
Trinity, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Chicago Hospital
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
St Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States
Billings Clinic
Billings, Montana, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
OhioHealth Research and Innovation Institute
Columbus, Ohio, United States
Trinity West Hospital
Steubenville, Ohio, United States
Abington Memorial Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Avera Heart Hospital of South Dakota
Sioux Falls, South Dakota, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Trinity Mother Health Systems
Tyler, Texas, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Commonwealth University Health System
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Froedtert Memorial Lutheran Hospital - Medical College of Wisconsin
Milwaukee, Wisconsin, United States
St Vincent's Hospital
Melbourne, Victoria, Australia
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Ste Foy, Quebec, Canada
Queen Mary Hospital
Hong Kong, Hong Kong, China
Hillel Yaffe Medical Center
Hadera, , Israel
Rambam Medical Center
Haifa, , Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Institut Jantung Negara
Kuala Lumpur, , Malaysia
University Malaya Medical Center
Kuala Lumpur, , Malaysia
National Heart Centre
Singapore, , Singapore
National University Hospital, Singapore
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BSC-CDM00047737
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.