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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01781078




Registration number
NCT01781078
Ethics application status
Date submitted
25/01/2013
Date registered
31/01/2013
Date last updated
3/12/2019

Titles & IDs
Public title
ImageReady(TM) MR Conditional Pacing System Clinical Study
Scientific title
ImageReady(TM) MR Conditional Pacing System Clinical Study
Secondary ID [1] 0 0
BSC-CDM00047737
Universal Trial Number (UTN)
Trial acronym
SAMURAI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bradycardia 0 0
Sinus Node Dysfunction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - MRI
Treatment: Devices - ImageReady System implant

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


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

Treatment: Devices: ImageReady System implant
Pacemaker and lead(s) implant

Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
MRI Visit + 1 Month
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
MRI + 1 Month Visit
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
MRI + 1 Month Visit
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
3 months post implant

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
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United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
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Maryland
Country [8] 0 0
United States of America
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Michigan
Country [9] 0 0
United States of America
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Minnesota
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United States of America
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Montana
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
China
State/province [21] 0 0
Hong Kong
Country [22] 0 0
Israel
State/province [22] 0 0
Hadera
Country [23] 0 0
Israel
State/province [23] 0 0
Haifa
Country [24] 0 0
Israel
State/province [24] 0 0
Tel Aviv
Country [25] 0 0
Israel
State/province [25] 0 0
Tel Hashomer
Country [26] 0 0
Malaysia
State/province [26] 0 0
Kuala Lumpur
Country [27] 0 0
Singapore
State/province [27] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01781078
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ronald Berger, MD, PhD
Address 0 0
Johns Hopkins Hospital, Carnegie 530, 600 N. Wolfe St, Baltimore, MD 21287
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications