试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 275
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects who are indicated for implantation of an ICD at the time of study
- •enrollment.
- •o Subjects who are able to undergo a pectoral implant.
- •o Subjects who are receiving an ICD for the first time.
- •o Subjects who are able and willing to undergo elective MRI scanning without
- •sedation.7,8
- •o Subjects who are geographically stable and available for follow-up at the study
- •site for the length of the study.
- •Subjects who are at least 18 years of age (or older, if required by local law)
排除标准
- •Subjects with a history of significant tricuspid valvular disease9.
- •o Subjects for whom a single dose of 1.0mg dexamethasone sodium phosphate
- •and/or dexamethasone acetate may be contraindicated.
- •o Subjects who require a legally authorized representative to obtain informed
- •o Subjects undergoing device upgrades, change-outs, lead extractions, and/or lead
- •or device revisions.
- •o Subjects with abandoned or capped leads.
- •o Subjects who require an indicated MRI scan, other than those specifically
- •described in the Evera MRI• study, before the one-month post-MRI/waiting
- •period follow-up (approximately 4 months post-implant).
- •o Subjects with a non-MRI compatible device (such as neurostimulators) or
- •material implant (e.g., non-MRI compatible sternal wires, neurostimulators,
- •biostimulators, metals or alloys).
- •o Subjects with medical conditions that preclude the testing required by the CIP or
- •limit study participation.
- •o 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 the
- •Evera MRI• study. Co-enrollment in concurrent trials is only allowed when
- •documented pre-approval is obtained from the Medtronic study manager.
- •o Female patient who is pregnant, or of childbearing potential and not on a reliable
- •form of birth control. Women of childbearing potential are required to have a
- •negative pregnancy test within seven (7) days prior to device implant.10
- •o Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).
研究者
相似试验
招募中
不适用
EVA Study (ESHRE / VCUAM / ASRM)GENITALEFEHLBILDUNGEDRKS00025001niversitätsklinik für Gynäkologie,Geburtshilfe und gynäkologischer Endokrinologie, Kepleruniversitätsklinikum Johannes Kepler Universität Linz150
尚未招募
1 期
Studying the effect of (music therapy) Raga Bageshri in patients prone to be diabetic (Prediabetes) comparing with previously treated prediabetic patientCTRI/2024/07/071098Sneha Santosh Banchhade
已完成
3 期
Clinical study of Aromatherapy Oil in females suffering from stress related anxietyCTRI/2016/03/006715Marico Ltd48
已完成
2 期
Clinical Trial of Ayurvedic Medicinal Oil KK786 in stress related anxietyCTRI/2017/06/008796Emami Ltd30
尚未招募
不适用
A Clinical Study to evaluate the effect of an Ayurvedic Formulation in Shwasa (Respiratory disorder)CTRI/2021/11/038133Vinod Kumar R H