ImageReady(TM) MR Conditional Pacing System Clinical Study

Bradycardia Clinical Trial

— SAMURAI  

Official title:

ImageReady(TM) MR Conditional Pacing System Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781078
• Other study ID #: BSC-CDM00047737
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: September 11, 2019

Study information

• Verified date: November 2019
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: September 11, 2019
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Sick Sinus Syndrome
• Sinus Node Dysfunction

Intervention

Radiation:
• MRI
The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment

Device:
• ImageReady System implant
Pacemaker and lead(s) implant

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Melbourne	Victoria
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Ste Foy	Quebec
China	Queen Mary Hospital	Hong Kong	Hong Kong
Israel	Hillel Yaffe Medical Center	Hadera
Israel	Rambam Medical Center	Haifa
Israel	The Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Sheba Medical Center	Tel Hashomer
Malaysia	Institut Jantung Negara	Kuala Lumpur
Malaysia	University Malaya Medical Center	Kuala Lumpur
Singapore	National Heart Centre	Singapore
Singapore	National University Hospital, Singapore	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
United States	Emory University Hospital	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Billings Clinic	Billings	Montana
United States	Martha Jefferson Hospital	Charlottesville	Virginia
United States	University of Chicago Hospital	Chicago	Illinois
United States	OhioHealth Research and Innovation Institute	Columbus	Ohio
United States	Medical City Dallas Hospital	Dallas	Texas
United States	St Mary's Duluth Clinic Regional Heart Center	Duluth	Minnesota
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	USC Medical Center	Los Angeles	California
United States	Banner Heart Hospital	Mesa	Arizona
United States	Froedtert Memorial Lutheran Hospital - Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Orlando Regional Medical Center	Orlando	Florida
United States	Abington Memorial Hospital	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University Health System	Richmond	Virginia
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	United Heart and Vascular Clinic	Saint Paul	Minnesota
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Avera Heart Hospital of South Dakota	Sioux Falls	South Dakota
United States	Trinity West Hospital	Steubenville	Ohio
United States	University Community Hospital	Trinity	Florida
United States	Trinity Mother Health Systems	Tyler	Texas
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  Israel,  Malaysia,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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