ACTRN12622000473763招募中未知
Safety and Technical Performance Evaluation of the Emboliner Embolic Protection Device: A New Zealand Experience
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •The subject must present with symptomatic severe aortic stenosis and be eligible for treatment with either an Edwards Sapien or Medtronic Evolut valve and corresponding TAVR procedure according to current guidelines and have consented to the TAVR procedure.
- •The subject and the treating physician agree that the subject will return for required post-procedure follow-up visit.
- •The subject or the subject's legal representative has been informed of the nature of the trial, has agreed to its provisions, and has provided written informed consent as approved by the IRB/EC of the respective clinical site.
- •The subject must be 18 years or older at the time of consent.
排除标准
- •Subject is not undergoing TAVR via the trans-femoral route.
- •Subject has severe allergy or contraindication to aspirin, heparin, bivalirudin, clopidogrel, and/or contrast sensitivity that cannot be adequately controlled.
- •Subject has uncorrected bleeding disorder.
- •Subject has hypercoagulable states that cannot be corrected.
- •Subject has known diagnosis of acute myocardial infarction (AMI) within the established study period.
- •Subject has a history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation.
- •Subject presents with cardiogenic shock, hemodynamic instability requiring inotropic support or mechanical heart assistance, or severe hypotension at the time of screening.
- •Subject has a history of a stroke or transient ischemic attack (TIA) within the established study period.
- •Subject's valve/valve disease is not indicated for use with the Emboliner System.
- •Subject has blood dyscrasias.
- •Subject has hypertrophic cardiomyopathy with or without obstruction.
- •Subject has severe ventricular dysfunction.
- •Subject has echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation.
- •Subject has an active infection.
- •Subject has neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
- •Subject has undergone carotid stenting or carotid endarterectomy within the previous 6 months; or subject has symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant CEA/stenting.
- •Subject presents with renal failure at the time of screening.
- •Subject has a planned treatment with any other investigational device or procedure during the study period.
- •Subject has undergone balloon valvuloplasty (BAV) within the established period prior to treatment.
- •Subject is planning to undergo any other cardiac surgical or interventional procedure.
- •Subject has a need for emergency surgery.
- •Subject is pregnant or nursing, or subject intends to become pregnant during the term of the study.
- •Subject is unable or unwilling to complete all required screening and/or follow-up assessments, including subjects with active major psychiatric disease; with severe visual, auditory, or learning impairment; or who are unable to comprehend English.
- •The investigator considers participation in the study to not be in the subject’s best interest.
- •Subject presents with anatomical limitations precluding the use of the investigational device.
研究者
相似试验
已完成
不适用
Evaluation of the performance and safety of the intravascular ivCGM continuous glucose monitoring system in hospitalized patients in critical care unitsHospitalized patients in cardiac surgery ICU.E10E11Type 2 diabetes mellitusType 1 diabetes mellitusDRKS00027085A. Menarini Diagnostics S.r.l.35
已完成
1 期
Evaluation of the Safety and Tolerability of the ‘LeVe CPAP Flow Generator’ in Healthy Volunteers at Mengo Hospital in Kampala UgandaRespiratoryPACTR202105734146484Mengo Hospital20
招募中
不适用
The evaluation for safety and effectiveness of the laparoscopic radical hysterectomy and pelvic lymphadenectomy for stage IA, IB and IIA uterine cervical cancer.terine cervical cancerJPRN-UMIN000016183agoya University Graduate School of Medicine, Department of Obstetrics and Gynecology10
已完成
不适用
Evaluation of the safety and effectiveness of the MID-C/ApiFix system in adolescent idiopathic scoliosis.Spinal curvature1002837710005944NL-OMON43676Vrije Universiteit Medisch Centrum33
进行中（未招募）
Unknown
Safety and effectiveness clinical evaluation of the range of injectable medical devices HYDRAGEL C in facial aesthetic treatmentSubjects across groups present with moderate to severe facial aesthetic concerns, including peri-oral lines, nasolabial folds, lip volume deficits, and cheeks/cheekbones volume deficit, as gauged by various dermatological scalesSkin and Connective Tissue DiseasesISRCTN13586698ouna Aesthetics75