跳至主要内容
临床试验/NCT06503965
NCT06503965招募中不适用

Design and Rationale of the National Multicenter Tunisian Registry of Trans Catheter Aortic Valve Implantation Registry

Les Laboratoires des Médicaments Stériles1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年9月23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
VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint

研究概览

简要总结

Transcatheter aortic valve implantation (TAVI) has emerged as a transformative therapy for patients with severe aortic stenosis, particularly those designated high-risk or inoperable for traditional surgical valve replacement. Despite its increasing adoption worldwide, there re-mains a paucity of data regarding TAVI outcomes in Tunisian patients. In response to this gap in knowledge, the investigators propose the establishment of the Tunisian TAVI Registry, a multicenter initiative aimed at comprehensively documenting the clinical characteristics, procedural de-tails, and short- and long-term outcomes of TAVI procedures across Tunisia. The TAVI.TN registry will enroll consecutive patients undergoing TAVI procedures at participating centers across Tunisia, between 2013 and 2024 with a retrospective arm and a prospective arm. The TAVI-TN Registry represents a significant step towards enhancing our understanding of TAVI outcomes in the Tunisian population. By systematically capturing real-world data, this initiative aims to inform clinical decision-making, improve patient care, and contribute to the advancement of TAVI practices in Tunisia and beyond.

研究设计

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

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

入选标准

  • Any Tunisian patient who was treated with TAVI implantation in Tunisia

排除标准

  • Patients who are not Tunisians
  • Patients not agreeing to sign consent, witnesses not agreeing to sign consent (family member)

结局指标

主要结局

VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint

时间窗: From 30 days post procedure to completion of at least 2 years of follow up

* All-cause mortality * All stroke (disabling and non-disabling) * Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure * NYHA (New York Heart Association) class III or IV functional classification of heart failure * Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, Effective Orifice Area (EOA) ≤0.9-1.1 cm2(c) and/or Doppler Velocity Integral (DVI) \<0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation

次要结局

  • VARC defined 'Device success' composite endpoint(30 days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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