NCT01617720已完成不适用
MITRAFIT Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)
Edwards Lifesciences2 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2012年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- • Ability of the Cardinal ring to reduce mitral valve regurgitation
研究概览
简要总结
This Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patient is a candidate for mitral valve repair, with our without concomitant procedures.
- •Subject is willing to give informed consent for collection of his/her clinical data.
排除标准
- •Severe organic lesions with retracted chordae
- •Congenital malformations with lack of valvular tissue
- •Severe valvular calcifications
- •Evolving bacterial endocarditis
- •Known Sensitivity to Nickel or Chromium
结局指标
主要结局
• Ability of the Cardinal ring to reduce mitral valve regurgitation
时间窗: 30 day
• Percentage of patients in whom the size of the ring is adjusted
时间窗: 6 months
• Technical feasibility of adjustment.
时间窗: 6 months
The ability of the surgeon to adjust the Cardinal ring when required, will be measured on a scale of 1-3 (1- successfull, 3- unsuccessful)
• The occurrence of serious device related adverse events in all patients.
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
MitraClip for the Treatment of Moderate Functional Mitral Regurgitation: EVOLVE-MRMitral Valve Regurgitation Due to Cardiomyopathy (Disorder)Heart FailureMitral RegurgitationNCT03705312Montreal Heart Institute174
招募中
不适用
MitraClip® RegistryMitral RegurgitationNCT02033811Klinik für Kardiologie, Pneumologie und Angiologie200
终止
不适用
Optimizing Clinical Outcomes in Patients Undergoing Mitral Transcatheter Edge-to-edge Repair (M-TEER) for Severe Functional Mitral Regurgitation Towards Improved Guideline-directed Medical TherapyMitral Regurgitation FunctionalM-TEERHeart FailureNCT06702527Institut für Pharmakologie und Präventive Medizin9
终止
不适用
Improving Mitral Repair for Functional Mitral RegurgitationCardiovascular DiseasesHeart DiseaseValvular Heart DiseaseMitral Valve DiseaseCardiomyopathyCongestive Heart FailureCoronary Artery DiseaseNCT03366649Emory University34
Unknown
不适用
Transcatheter Mitral Valve Repair as Bridge Therapy to Heart TransplantationHeart FailureEnd-stage Heart FailureMitral RegurgitationNCT04293575Scientific Institute San Raffaele150