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临床试验/NCT04031274
NCT04031274Unknown不适用

International Multicenter Registry of Patients With Concomitant Aortic and Mitral Valve Disease Undergoing Transcatheter Aortic Valve Implantation - The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10,000
试验地点
1
主要终点
Overall mortality

研究概览

简要总结

an international multicentre registry designed to answer 3 clinical questions:

  1. Describing the characteristics and outcomes of current patients undergoing aortic + mitral transcatheter heart valve procedures.
  2. Better understanding of the predictors for MR regression following isolated TAVI and consequently estimating the fraction of patients who will be suitable for TMVR/r post TAVI
  3. Examining the clinical outcomes of patients with significant MR post TAVI who subsequently underwent TMVR/r compared to those left for medical management.

详细描述

Transcatheter aortic valve implantation (TAVI) , has revolutionised the treatment for severe aortic stenosis (AS) over the past decade. The use of TAVI is growing exponentially, and the current trend of treating younger and lower risk patients is expected to continue [1], with TAVI eventually becoming the treatment of choice for the majority of severe AS patients. When treating younger, lower risk patients, whose life expectancy is longer than that of current typical TAVI patients, long term prognosis with good functional status is as significant as periprocedural morbidity when selecting the preferred treatment strategy. Consequently, treatment of comorbidities, especially cardiac comorbidities is of paramount importance.

Significant mitral regurgitation (MR) is present in approximately 25% of patients with severe AS [2], there are several pathophysiological mechanisms linking the two entities [3,4]. Significant MR is associated with worse prognosis in patients undergoing either surgical aortic valve replacement (SAVR) [5] or TAVI [6,7] . Using a surgical intervention, both AS and MR can be treated (albeit at a cost of increased perioperative mortality) [8], while treating both valves using a transcatheter technique in a single procedure is not customary. A sizeable fraction of patients from AS+MR will have some reduction in MR following TAVI [2], but unlike the case of surgical double valve replacement [6], the prognostic benefit of MR reduction following TAVI has not yet been shown [9].This issue may be of utmost importance in patients who are viable surgical candidates, in whom the feasibility of total surgical valvular treatment may be a "tiebreaker" when contemplating the pros and cons of transcatheter vs. surgical intervention.

The percutaneous treatment options for MR with either transcatheter mitral valve replacement (TMVR) or repair (TMVr) are expanding and clinical experience is growing [1], raising the option for a combined percutaneous treatment for patients with AS+MR - either a combined TAVI + TMVR/r procedure, or performing TAVI first followed by a TMVR/r for those patients whose MR does not improve sufficiently following an isolated TAVI. One multicentre study from Spain dedicated to patients with significant MR undergoing TAVI found two predictors for persistence of MR following TAVI (mitral annular diameter of >35.5 mm and the degree of calcification of the mitral apparatus by multidetector computed tomography), and also suggested that only a small fraction of such patients will be suitable for TMVR/r, but this was based on a small number of patients (n=177) [10].

To examine whether such approach is appropriate, several evidence gaps will need to be addressed:

  1. describing the characteristics and outcomes of current patients undergoing aortic + mitral transcatheter heart valve procedures.
  2. Better understanding of the predictors for MR regression following isolated TAVI and consequently estimating the fraction of patients who will be suitable for TMVR/r post TAVI
  3. Examining the clinical outcomes of patients with significant MR post TAVI who subsequently underwent TMVR/r compared to those left for medical management.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • For phase 1:
  • TAVI+TMVR/r (either as a single or staged procedure).
  • Follow up of at least 30 days post TMVR/r (unless deceased) Available TTE and/or TOE data pre and post TAVI + TMVR/r
  • For phase 2:
  • Patients undergoing successful isolated TAVI
  • Assessment of MR grade prior and post TAVI

排除标准

  • Death within 30 days post TAVI

结局指标

主要结局

Overall mortality

时间窗: UP to 10 years of follow up

Death from any cause

次要结局

  • Periprocedural complications(In-hospital/30 days)
  • Periprocedural mortality(In-hospital/30 days)
  • Mitral regurgitation grade(1,3,6,12 months and up to 10 years of follow up)
  • NYHA Class(1,3,6,12 months and up to 10 years of follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guy Witberg

Consultant cardiologist

Rabin Medical Center

研究点 (1)

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