NL-OMON55513已完成不适用
Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for Reduction of Defibrillation Energies - ASE Study protocol C2081
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject is scheduled to receive a de novo S-ICD system implant per labeled
- •2. Passing S-ICD screening ECG performed per applicable user's manual.
- •3. Subject is expected to be implanted with a left parasternal S-ICD electrode.
- •4. Subject*s planned S-ICD implant procedure will include at least one VF
- •conversion testing at 65 J.
- •5. Subject is willing and capable of providing informed consent specific to
- •local and national laws.
- •6. Subject is age 18 or above, or of legal age to give informed consent
- •specific to local and national law.
排除标准
- •1. Subject has an unusual chest anatomy (eg. pectus excavatum and pectus
- •carinatum) that might impede the ability to temporarily insert a second S-ICD
- •2. Subject has a left ventricular ejection fraction less than or equal to 20%
- •within 3 months prior to enrollment.
- •3. Subject has NYHA Class IV or unstable Class III heart failure.
- •4. Subject that, in the opinion of the investigator, cannot tolerate the DFT
- •testing required by this protocol.
- •5. Subject that, in the opinion of the investigator, is at increased risk for
- •VF conversion failure.
- •6. Subject is morbidly obese, defined as BMI greater than or equal to 35.
- •7. Subject has an active infection or has been treated for infection within the
- •past 30 days.
- •8. Subject that, in the opinion of the investigator, has an increased risk of
- •9. Subject is currently requiring/receiving dialysis.
- •10. Subject has insulin-dependent diabetes.
- •11. Subject had/has any prior or planned other surgical procedure within ±30
- •days of enrollment.
- •12. Subject is receiving immunosupressive therapy or has a condition that
- •compromises their immune system.
- •13. Subject had episodes of atrial fibrillation or atrial flutter within the 4
- •week period prior to enrollment or during the period of time between enrollment
- •and the start of implant procedure.
- •14. Subject that, in the opinion of the investigator, has an increased risk for
- •thromboembolic event.
- •15. Subject that, in the opinion of the investigator, has an increased risk of
- •excessive bleeding.
- •16. Subject is currently on an active heart transplant list.
- •17. Subjects with documented life expectancy of less than 12 months.
- •18. Subject has any other electrically active implanted device that cannot be
- •temporarily deactivated during the implant (includes components or accessories
- •present such as pulse generators, non-capped leads or leads with breached
- •insulation, implantable cardiac monitors, implantable stimulators).
- •19. Subject is enrolled in a concurrent study, with the exception of local
- •mandatory governmental registries and observational studies/registries, without
- •prior written approval from Boston Scientific.
- •20. Women of childbearing potential who are or might be pregnant at the time of
- •the S-ICD implant procedure.
研究者
相似试验
已完成
不适用
Acute Feasibility Investigation of a New S-ICD ElectrodeVentricular FibrillationNCT03802110Boston Scientific Corporation42
已完成
不适用
S-ICD System Clinical InvestigatioVentricular tachyarrhythmias10007521NL-OMON36228Cameron Health90
已完成
不适用
Intelligent Spine Interface, Clinical (ISI-C)Spinal Cord InjuryNCT04302259Rhode Island Hospital3
Unknown
不适用
Product evaluation of a novel device designed to manage fecal incontinence in hospitalized bed-ridden patients.CTRI/2014/02/004429Consure Medical Pvt Ltd10
招募中
Unknown
Investigation of the feasibility of a new small-diameter therapeutic endoscope for endoscopic submucosal dissection of the esophagogastric junctiotumors grow from esophagogastric junctionJPRN-UMIN000050493Keio Unversity10