NL-OMON50262招募中不适用
AveirTM DR i2i Study: Aveir Dual-Chamber Leadless i2i IDE Study - AVEIR DR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
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 must have at least one of the clinical indications before device
- •implant in adherence
- •with ACC/AHA/HRS/ESC dual chamber pacing guidelines
- •2. Subject is >= 18 years of age or age of legal consent, whichever age is
- •3. Subject has a life expectancy of at least one year
- •4. Subject is willing to comply with clinical investigation procedures and
- •agrees to return to clinic
- •for all required follow-up visits, tests, and exams
- •5. Subject has been informed of the nature of the clinical investigation,
- •agrees to its provisions
- •and has provided a signed written informed consent, approved by the
排除标准
- •1. Subject is currently participating in another clinical investigation that
- •may confound the results
- •of this study as determined by the Sponsor
- •2. Subject is pregnant or nursing and those who plan pregnancy during the
- •clinical investigation
- •follow-up period
- •3. Subject has presence of anatomic or comorbid conditions, or other medical,
- •psychological conditions that, in the investigator*s opinion, could
- •confound the assessment of
- •the investigational device and/or implant procedure, limit the
- •subject*s ability to participate in
- •the clinical investigation or to comply with follow-up requirements of
- •the clinical investigation
- •4. Subject has a known allergy or hypersensitivity to < 1 mg of dexamethasone
- •phosphate or any blood or tissue contacting material listed in the IFU
- •5. Subject has an implanted vena cava filter or mechanical tricuspid valve
- •6. Subject has pre-existing, permanent endocardial pacing or defibrillation
- •leads (does not include
- •lead fragments)
- •7. Subject has current implantation of either conventional or subcutaneous
- •implantable
- •cardioverter defibrillator (ICD) or cardiac resynchronization therapy
- •(CRT) device
- •8. Subject has an implanted leadless cardiac pacemaker (except for an Aveir
- •ventricular LP)
- •9. Subject is implanted with an electrically-active implantable medical device
- •with stimulation
- •capabilities (such as neurological or cardiac stimulators)*
- •10. Subject is unable to read or write
- •*NOTE: Does not apply to a medical device with no known impact to the Aveir
- •Leadless Pacemaker System, including the Aveir Link Module. Patient evaluation
- •and the decision to implant the LP should take into account the presence of
- •other active implantable devices and should include consultation with the
- •Sponsor and/or manufacturer of the co-existing device.
研究者
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