ImageReady(TM) MR Conditional Pacing System Clinical Study (SAMURAI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01781078
Recruitment Status : Active, not recruiting
First Posted : January 31, 2013
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Bradycardia Sinus Node Dysfunction Radiation: MRI Device: ImageReady System implant Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ImageReady(TM) MR Conditional Pacing System Clinical Study
Study Start Date : February 2013
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans
U.S. FDA Resources

Arm Intervention/treatment
Experimental: MRI Group
Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
Radiation: MRI
The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
Other Name: MR Scan
Device: ImageReady System implant
Pacemaker and lead(s) implant
Other Names:
  • Single chamber pacemaker implant
  • Dual chamber pacemaker implant
  • Pace/ Sense pacemaker lead implant
Experimental: 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.
Device: ImageReady System implant
Pacemaker and lead(s) implant
Other Names:
  • Single chamber pacemaker implant
  • Dual chamber pacemaker implant
  • Pace/ Sense pacemaker lead implant

Primary Outcome Measures :
  1. Proportion of Participants Without MR Scan-related Complications [ Time Frame: MRI Visit + 1 Month ]
    The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who undergo any portion of the MRI scan sequences. Safety will be confirmed by evaluating the MRI scan-related Complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month Visit.

  2. Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit [ Time Frame: MRI + 1 Month Visit ]

    The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to RF field-induced heating, which in turn may cause elevated pacing thresholds. Primary Effectiveness Endpoint 1 will evaluate any chronic effects from lead heating that will be seen through increased pacing threshold at the MRI Visit + 1 Month follow-up.

    Subjects with an increase in pacing thresholds s 0.5V (at 0.5 ms) from pre-MR Scan/Control Group visit to MRI/Control visit + 1 Month follow-up were considered a success. A success rate was calculated for both the MRI and the Control Groups.

  3. Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit [ Time Frame: MRI + 1 Month Visit ]
    The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to Radiofrequency (RF) field-induced heating. Primary Effectiveness Endpoint 2 will evaluate any chronic effects from lead heating that will be seen through decreased sensed amplitude at the MRI Visit + 1 Month follow-up. Data were analyzed separately by chamber, Right Atrium (RA) and Right Ventricle (RV), for this endpoint.

Secondary Outcome Measures :
  1. Proportion of Participants Without ImageReady System-related Complications [ Time Frame: 3 months post implant ]
    Overall safety of the ImageReady System will be confirmed by evaluating system-related complications that occur from system implant through 3 months post implant for all subjects who underwent an implant procedure and and reached 91 days of follow-up.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01781078

  Hide Study Locations
United States, Arizona
Banner Heart Hospital
Mesa, Arizona, United States, 85206
United States, California
USC Medical Center
Los Angeles, California, United States, 90033
University of California, San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
University Community Hospital
Trinity, Florida, United States, 34655
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago Hospital
Chicago, Illinois, United States, 60637
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Michigan
William Beaumont Hospital
Royal Oaks, Michigan, United States, 48098
United States, Minnesota
St Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, United States, 55805
United Heart and Vascular Clinic
St Paul, Minnesota, United States, 55102
United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
United States, Ohio
OhioHealth Research and Innovation Institute
Columbus, Ohio, United States, 43214
Trinity West Hospital
Steubenville, Ohio, United States, 43952
United States, Pennsylvania
Abington Memorial Hospital
Philadelphia, Pennsylvania, United States, 19001
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Dakota
Avera Heart Hospital of South Dakota
Sioux Falls, South Dakota, United States, 57108
United States, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Trinity Mother Health Systems
Tyler, Texas, United States, 75701
United States, Virginia
Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22911
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23219
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
Froedtert Memorial Lutheran Hospital - Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, Victoria
St Vincent's Hospital
Melbourne, Victoria, Australia
Canada, Quebec
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Ste Foy, Quebec, Canada
China, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong, China, 00000
Hillel Yaffe Medical Center
Hadera, Israel
Rambam Medical Center
Haifa, Israel, 31096
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sheba Medical Center
Tel Hashomer, Israel
Institut Jantung Negara
Kuala Lumpur, Malaysia, 50400
University Malaya Medical Center
Kuala Lumpur, Malaysia, 50603
National Heart Centre
Mistri Wing, Singapore, 168752
National University Hospital, Singapore
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Ronald Berger, MD, PhD Johns Hopkins Hospital, Carnegie 530, 600 N. Wolfe St, Baltimore, MD 21287

Responsible Party: Boston Scientific Corporation Identifier: NCT01781078     History of Changes
Other Study ID Numbers: BSC-CDM00047737
First Posted: January 31, 2013    Key Record Dates
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017
Last Verified: April 2017

Keywords provided by Boston Scientific Corporation:
Single chamber pacing
Dual chamber pacing
MR scans

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block