ImageReady(TM) MR Conditional Pacing System Clinical Study (SAMURAI)

Boston Scientific

Status: Completed

Conditions: Bradycardia; Sinus Node Dysfunction

Treatments: Radiation: MRI; Device: ImageReady System implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01781078

BSC-CDM00047737

Details and patient eligibility

About

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

Enrollment: 363 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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363 participants in 2 patient groups

MRI Group

Experimental group

Description:

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

Treatment:

Device: ImageReady System implant

Radiation: MRI

Control Group

Experimental group

Description:

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:

Device: ImageReady System implant