Overview

This trial is active, not recruiting.

Conditions bradycardia, sinus node dysfunction
Treatments mri, imageready system implant
Sponsor Boston Scientific Corporation
Start date February 2013
End date October 2014
Trial size 363 participants
Trial identifier NCT01781078, BSC-CDM00047737

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
mri MRI
The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
imageready system implant Single chamber pacemaker implant
Pacemaker and lead(s) implant
(Experimental)
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.
imageready system implant Single chamber pacemaker implant
Pacemaker and lead(s) implant

Primary Outcomes

Measure
Proportion of participants without MR scan-related complications
time frame: MRI Visit + 1 Month
Change in pacing threshold from pre-MRI scan/ Control Group Visit to MRI + 1 Month Visit
time frame: MRI + 1 Month Visit
Change in sensed amplitude from pre-MRI scan/ Control Group Visit to MRI + 1 Month Visit
time frame: MRI + 1 Month Visit

Secondary Outcomes

Measure
Proportion of participants without ImageReady System-related complications
time frame: 3 months post implant

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title ImageReady(TM) MR Conditional Pacing System Clinical Study
Principal investigator Ronald Berger, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.