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ImageReady(TM) MR Conditional Pacing System Clinical Study

NCT01781078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2019-12-03

Study results available
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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

Conditions

  • Bradycardia
  • Sinus Node Dysfunction

Interventions

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Ronald Berger, MD, PhD · Johns Hopkins Hospital, Carnegie 530, 600 N. Wolfe St, Baltimore, MD 21287

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-10-31
Completion
2019-09-11

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01781078 on ClinicalTrials.gov