ImageReady(TM) MR Conditional Pacing System Clinical Study
SAMURAI
1 other identifier
interventional
363
7 countries
41
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2013
CompletedFirst Posted
Study publicly available on registry
January 31, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedResults Posted
Study results publicly available
April 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2019
CompletedDecember 3, 2019
November 1, 2019
1.7 years
January 25, 2013
April 7, 2017
November 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Proportion of Participants Without MR Scan-related Complications
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.
MRI Visit + 1 Month
Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group 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.
MRI + 1 Month Visit
Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group 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.
MRI + 1 Month Visit
Secondary Outcomes (1)
Proportion of Participants Without ImageReady System-related Complications
3 months post implant
Study Arms (2)
MRI Group
EXPERIMENTALThose subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
Control Group
EXPERIMENTALThose 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.
Interventions
The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
Pacemaker and lead(s) implant
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Banner Heart Hospital
Mesa, Arizona, 85206, United States
USC Medical Center
Los Angeles, California, 90033, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Orlando Regional Medical Center
Orlando, Florida, 32806, United States
University Community Hospital
Trinity, Florida, 34655, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
University of Chicago Hospital
Chicago, Illinois, 60637, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
William Beaumont Hospital
Royal Oak, Michigan, 48098, United States
St Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, 55805, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102, United States
Billings Clinic
Billings, Montana, 59101, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
OhioHealth Research and Innovation Institute
Columbus, Ohio, 43214, United States
Trinity West Hospital
Steubenville, Ohio, 43952, United States
Abington Memorial Hospital
Philadelphia, Pennsylvania, 19001, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Avera Heart Hospital of South Dakota
Sioux Falls, South Dakota, 57108, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Trinity Mother Health Systems
Tyler, Texas, 75701, United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22911, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University Health System
Richmond, Virginia, 23219, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Froedtert Memorial Lutheran Hospital - Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, 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, 00000, China
Hillel Yaffe Medical Center
Hadera, Israel
Rambam Medical Center
Haifa, 31096, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Sheba Medical Center
Tel Litwinsky, Israel
Institut Jantung Negara
Kuala Lumpur, 50400, Malaysia
University Malaya Medical Center
Kuala Lumpur, 50603, Malaysia
National Heart Centre
Singapore, 168752, Singapore
National University Hospital, Singapore
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kelly Aspinwall
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Berger, MD, PhD
Johns Hopkins Hospital, Carnegie 530, 600 N. Wolfe St, Baltimore, MD 21287
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2013
First Posted
January 31, 2013
Study Start
February 1, 2013
Primary Completion
October 1, 2014
Study Completion
September 11, 2019
Last Updated
December 3, 2019
Results First Posted
April 11, 2017
Record last verified: 2019-11