At a glance
ClinicalIndex Comparison RecordN/ACompleted· 363 enrolled
Drug / intervention
MRI +1 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ImageReady(TM) MR Conditional Pacing System Clinical Study
In Brief
A clinical study evaluating MRI and ImageReady System implant for Bradycardia and Sinus Node Dysfunction. Completed, enrolled 363 participants across 41 sites in 7 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBradycardia, Sinus Node Dysfunction
CountriesAustralia, Canada, China, Israel, Malaysia, Singapore, United States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartFeb 2013
Primary CompletionOct 2014
Study CompletionSep 2019
TodayJul 2026
First PostedJan 31, 2013
Enrollment StartFeb 1, 2013
Primary CompletionOct 1, 2014
Study CompletionSep 11, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.4 years ago
Interventions
MRIradiation
The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
ImageReady System implantdevice
Pacemaker and lead(s) implant