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临床试验/NCT04914468
NCT04914468招募中不适用

Hamburg Transcatheter Mitral Valve Replacement Registry

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
All-cause mortality

研究概览

简要总结

The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with mitral valve disease that undergo transcatheter mitral valve replacement (TMVR) screening. In particular, long-term durability and function of implanted bioprosteses is of utmost interest for both patients and clinicians. Moreover, this study aimes to investigate and compare the different treatment strategies patients undergo after successful or unsuccessful screening for TMVR.

详细描述

Mitral valve regurgitation (MR) emerges as the most frequent valvular heart disease in developed coun-tries with prevalence increasing with age. Mitral valve repair is the gold standard therapeutic strategy in primary MR and is recommended in patients with secondary MR who are in need of revascularization. However, in patients with secondary MR mitral valve repair is associated with a higher rate of MR recurrence compared to mitral valve replacement. Nevertheless, elderly patients often are at high or prohibitive surgical risk and up to one half of all patients with severe MR are not referred to surgery. Transcatheter edge-to-edge mitral valve repair (TEER) constitutes a feasible and effective alternative, but eligibility for TEER is limited in some cases due to suboptimal anatomy or risk of mitral stenosis. Moreover, MR reduction is less predictable and, again, MR may reoccur. Transcatheter mitral valve replacement (TMVR) represents a complementary therapeutic approach for patients with severe MR. This novel therapy promises to reduce MR as durable as surgical valve replacement while reducing the procedural risk with an interventional approach.

The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with significant mitral valve disease, at high surgical risk with suboptimal anatomy for TEER, who undergo TMVR screening. In particular, long-term durability and function of implanted bioprosteses will be investigated. Additionally, this study aimes to investigate and compare the different treatment strategies patients undergo after successful or unsuccessful screening for TMVR (i.e., TMVR, TEER, surgery and medical therapy).

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 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation.
  • Individuals over the age of 18 years.
  • Patients with clinically relevant mitral valve disease, who undergo screening for TMVR.

排除标准

  • Insufficient knowledge of the German language, to understand study documents and interview without translation
  • Physical or psychological incapability to cooperate in the investigation

结局指标

主要结局

All-cause mortality

时间窗: 6-60 months

Incidence of death from any cause.

Cardiovascular mortality

时间窗: 6-60 months

Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident.

Rehospitalization for congestive heart failure

时间窗: 6-60 months

Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews.

Unplanned mitral valve intervention

时间窗: 6-60 months

Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or assist device implantation, e.g. as assessed by patient interviews.

Mitral regurgitation (MR) severity

时间窗: 6-60 months

Mitral regurgitation (MR) severity measured by transthoracic and/or transesophageal echocardiography. Assessment of MR severity according to current recommendations for valvular heart disease.

次要结局

  • Change in quality of life(6-60 months)
  • Change in 6-minute-walking-test (6MWT) distance(6-60 months)
  • Change in New York Heart Association (NYHA) functional class(6-60 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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