search
Back to results

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

Primary Purpose

Bradycardia, Sinus Node Dysfunction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MRI
ImageReady System implant
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia focused on measuring Single chamber pacing, Dual chamber pacing, MRI, MR scans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner Heart Hospital
  • USC Medical Center
  • University of California, San Francisco
  • Washington Hospital Center
  • Orlando Regional Medical Center
  • University Community Hospital
  • Emory University Hospital
  • University of Chicago Hospital
  • Alexian Brothers Medical Center
  • Johns Hopkins Hospital
  • William Beaumont Hospital
  • St Mary's Duluth Clinic Regional Heart Center
  • United Heart and Vascular Clinic
  • Billings Clinic
  • Hackensack University Medical Center
  • Long Island Jewish Medical Center
  • OhioHealth Research and Innovation Institute
  • Trinity West Hospital
  • Abington Memorial Hospital
  • University of Pittsburgh Medical Center
  • Avera Heart Hospital of South Dakota
  • Texas Cardiac Arrhythmia Research Foundation
  • Medical City Dallas Hospital
  • Trinity Mother Health Systems
  • Martha Jefferson Hospital
  • Sentara Norfolk General Hospital
  • Virginia Commonwealth University Health System
  • University of Washington Medical Center
  • Froedtert Memorial Lutheran Hospital - Medical College of Wisconsin
  • St Vincent's Hospital
  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  • Queen Mary Hospital
  • Hillel Yaffe Medical Center
  • Rambam Medical Center
  • The Tel Aviv Sourasky Medical Center
  • Sheba Medical Center
  • Institut Jantung Negara
  • University Malaya Medical Center
  • National Heart Centre
  • National University Hospital, Singapore
  • Tan Tock Seng Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MRI Group

Control Group

Arm Description

Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 25, 2013
Last Updated
November 19, 2019
Sponsor
Boston Scientific Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01781078
Brief Title
ImageReady(TM) MR Conditional Pacing System Clinical Study
Acronym
SAMURAI
Official Title
ImageReady(TM) MR Conditional Pacing System Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
September 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Sinus Node Dysfunction
Keywords
Single chamber pacing, Dual chamber pacing, MRI, MR scans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
363 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI Group
Arm Type
Experimental
Arm Description
Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
MRI
Other Intervention Name(s)
MR Scan
Intervention Description
The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
Intervention Type
Device
Intervention Name(s)
ImageReady System implant
Other Intervention Name(s)
Single chamber pacemaker implant, Dual chamber pacemaker implant, Pace/ Sense pacemaker lead implant
Intervention Description
Pacemaker and lead(s) implant
Primary Outcome Measure Information:
Title
Proportion of Participants Without MR Scan-related Complications
Description
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.
Time Frame
MRI Visit + 1 Month
Title
Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit
Description
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.
Time Frame
MRI + 1 Month Visit
Title
Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit
Description
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.
Time Frame
MRI + 1 Month Visit
Secondary Outcome Measure Information:
Title
Proportion of Participants Without ImageReady System-related Complications
Description
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.
Time Frame
3 months post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Berger, MD, PhD
Organizational Affiliation
Johns Hopkins Hospital, Carnegie 530, 600 N. Wolfe St, Baltimore, MD 21287
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Heart Hospital
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University Community Hospital
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Alexian Brothers Medical Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
St Mary's Duluth Clinic Regional Heart Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
United Heart and Vascular Clinic
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
OhioHealth Research and Innovation Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Trinity West Hospital
City
Steubenville
State/Province
Ohio
ZIP/Postal Code
43952
Country
United States
Facility Name
Abington Memorial Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Avera Heart Hospital of South Dakota
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Trinity Mother Health Systems
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Martha Jefferson Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Froedtert Memorial Lutheran Hospital - Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
St Vincent's Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
City
Ste Foy
State/Province
Quebec
Country
Canada
Facility Name
Queen Mary Hospital
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
00000
Country
China
Facility Name
Hillel Yaffe Medical Center
City
Hadera
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
The Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
Facility Name
Institut Jantung Negara
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
University Malaya Medical Center
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
National Heart Centre
City
Singapore
ZIP/Postal Code
168752
Country
Singapore
Facility Name
National University Hospital, Singapore
City
Singapore
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

ImageReady(TM) MR Conditional Pacing System Clinical Study

We'll reach out to this number within 24 hrs