ImageReady(TM) MR Conditional Pacing System Clinical Study

Completed · Not applicable

Conditions studied: Bradycardia, Sinus Node Dysfunction

In brief

The objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with the Conditions of Use included in the Boston Scientific MRI Technical Guide

Key facts

Study ID

NCT01781078

Run by

Boston Scientific Corporation

People needed

363

Starts

2013-02-01

Expected to finish

2019-09-11

Last updated by the study team

2019-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must have the ImageReady System as their initial (de novo) pacing system implant
• 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

You may not qualify if…

• Subject has or has had any pacing or ICD system implants
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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