Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 may not be 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
Clareo Health | ImageReady(TM) MR Conditional Pacing System Clinical Study
