Skip to main content
Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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

Keywords

Bradycardia Sinus Node Dysfunction Single chamber pacing Dual chamber pacing MRI MR scans

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • USC Medical Center
    Los Angeles, California, 90033, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Scientific Corporation
ID
NCT01781078
Lead Scientist
Byron Lee
Study Type
Interventional
Last Updated
April 2017