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

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

Study Overview

• Status: Completed
• Conditions: Bradycardia; Sinus Node Dysfunction
• Intervention / Treatment: Radiation: MRI; Device: ImageReady System implant

• Study Type: Interventional
• Enrollment (Actual): 363
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Without ImageReady System-related Complications	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.	3 months post implant

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Ronald Berger, MD, PhD, Johns Hopkins Hospital, Carnegie 530, 600 N. Wolfe St, Baltimore, MD 21287

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): September 11, 2019

Study Registration Dates

• First Submitted: January 25, 2013
• First Submitted That Met QC Criteria: January 29, 2013
• First Posted (Estimate): January 31, 2013

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: MRI; Single chamber pacing; Dual chamber pacing; MR scans
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Block; Bradycardia; Sick Sinus Syndrome
• Other Study ID Numbers: BSC-CDM00047737