CapSureFixÂ® Novus Model 5076 Lead MRI Study - 5076 MRI

India Medtronic Pvt Ltd0 个研究点目标入组 270 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Subjects who have Class I and II indication for implantation of a dual chamber pacemaker
•according to the ACC/AHA/HRS guidelines
•2. Subjects who are able to undergo a pectoral
•3. Subjects who: are receiving an IPG for the first time, or
•4. are receiving a replacement IPG connected
•to two previouslyâ??implanted Model 5076
•5. Subjects who are able and willing to undergo
•elective MRI scanning without sedation
•6. Subjects who are geographically stable and
•available for followâ??up at the study site for the length of the study

•1. Subjects with a mechanical tricuspid heart
•2. Subjects with a history of significant tricuspid valvular disease.
•3. Subjects for whom a single dose of 1.0mg
•dexamethasone acetate may be contraindicated.
•4. Subjects who require a legally authorized
•representative to obtain consent.
•5. Subjects who have abandoned (inactive)
•pacemaker and/or defibrillator leads
•6. Subjects who are immediate candidates for an
•7. Subjects who require an indicated MRI scan,
•other than those specifically described in the
•study, before the oneâ??month post MRI/waiting
•period followâ??up.
•8. Subjects with previously implanted active
•medical devices (exception Model 5076 Lead
•and Advisa MRI IPG).
•9. Subjects with a nonâ??MRI compatible device
•(such as ICDs or neurostimulators) or material
•implant (e.g., nonâ??MRI compatible sternal
•wires, neurostimulators, biostimulators,
•metals or alloys).
•10. Subjects with medical conditions that preclude the testing required by the protocol or limit study participation.
•11. Subjects who are enrolled or intend to
•participate in another clinical trial (of an
•investigational drug or device, new indication
•for an approved drug or device, or
•requirement of additional testing beyond
•standard clinical practice) during this clinical
•12. Pregnant women, or women of child bearing
•potential and who are not on a reliable form of
•birth control.

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