NCT03997305Unknown不适用
AltaValve Early Feasibility Study Protocol
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 24
- 主要终点
- Major Adverse Cardiac Event
研究概览
简要总结
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥ 18 years of age.
- •Subjects symptomatic New York Heart Association (NYHA) II-IV.
- •Subjects with severe MR as documented by echo.
- •Subjects who are at high risk for open-heart surgery as documented by the health care professional (e.g., Heart Team consisting of cardiac surgeon and interventional cardiologist in United States).
- •Abbreviated
排除标准
- •Inability to understand the study or a history of non-compliance with medical advice.
- •Unwilling or unable to sign the Informed Consent Form (ICF).
- •History of any cognitive or mental health status that would interfere with study participation.
- •Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)).
- •Female subjects who are pregnant or planning to become pregnant within the study period.
- •Known hypersensitivity or contraindication to aspirin, heparin, or Warfarin without adequate alternative medications.
- •Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
- •Known hypersensitivity to contrast media that cannot be adequately medicated.
- •Evidence of current Left Ventricular Ejection Fraction (LVEF) ≤30% (where current is defined as the latest LVEF measurement completed within 90 days prior to the index procedure).
- •Concurrent medical condition with a life expectancy of less than 12 months.
- •Prior mitral valve repair/replacement (excluding prior surgical mitral valve repair, annuloplasty, or MitraClip not interfering with AltaValve placement).
结局指标
主要结局
Major Adverse Cardiac Event
时间窗: 30 days
Cardiac death, stroke, mitral valve related repeated intervention
次要结局
- Device success(30 days)
- Change in MR grade(30 days)
- Technical success(Index procedure completion (Day 0))
- Procedural success(30 days)
研究者
研究点 (24)
Loading locations...
相似试验
招募中
不适用
ATLAS (AltaValve) Pivotal TrialMitral InsufficiencyMitral Valve IncompetenceMitral Valve RegurgitationMitral IncompetenceMitral RegurgitationNCT064657454C Medical Technologies, Inc.450
终止
Unknown
AltaValve Early Feasibility Study Protocol-Mitral Regurgitation-Mitral Insufficiency-Mitral Valve Incompetence-Mitral Valve Regurgitation-Mitral IncompetenceJPRN-jRCT10802249054C Medical Technologies, Inc.15
进行中（未招募）
不适用
Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device ImplantationHeart FailureNCT06682910Microtech Medical Technologies, Ltd15
已完成
不适用
Evaluation of the Integrated Radio Frequency Denervation System to Improve Glycemic Control in Type 2 Diabetic SubjectsDiabetes Mellitus, Type 2NCT04285554Metavention15
招募中
不适用
MASA Valve Early Feasibility StudyTetrology of FallotTransposition of Great VesselsRoss ProcedurePulmonary StenosisPulmonary AtresiaTruncus ArteriosusNCT05452720PECA Labs10