ImageReady(TM) MR Conditional Pacing System Clinical Study



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:8/30/2018
Start Date:February 2013
End Date:February 2019

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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


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
30
sites
270-05 76th Ave
New Hyde Park, New York 11040
(718) 470-7480
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1414 Kuhl Avenue
Orlando, Florida 32806
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Orlando, FL
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Austin, TX
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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801 North 29th Street
Billings, Montana 59107
406-238-2500
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Charlottesville, Virginia 22901
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Chicago, Illinois 60637
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Columbus, OH
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Duluth, MN
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Elk Grove Village, Illinois 60007
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Los Angeles, California 90033
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Melbourne, Victoria
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Mesa, Arizona 85206
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Norfolk, VA
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Philadelphia, Pennsylvania 19001
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Royal Oak, Michigan 48073
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Saint Paul, Minnesota 55102
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San Francisco, California 94143
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Sioux Falls, South Dakota 57108
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Steubenville, Ohio 43952
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Trinity, Florida 34655
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Tyler, Texas 75701
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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Washington,
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