NCT04735003招募中不适用
TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study
Marianna Adamo1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- All-cause death
研究概览
简要总结
This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment. The aim is to report clinical characteristics, procedural results and short- and long-term outcomes of patients undergoing transcatheter tricuspid valve interventions in Italian centres.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing transcatheter treatment of tricuspid regurgitation (native valve -with or without previous surgical valve repair - or degenerated bioprosthesis)
- •Patients who are willing and capable of providing informed consent, and participating in all follow-ups associated with this clinical investigation.
排除标准
- •Valve anatomy unsuitable for transcatheter tricuspid valve interventions.
- •Subjects who are unable or not willing to complete follow-up visits and examination for the duration of the study.
结局指标
主要结局
All-cause death
时间窗: 1-year
Cardiovascular death or heart failure hospitalization
时间窗: 1-year
次要结局
- Changes in medical therapy (i.e. diuretic dose)(30-day, 1-year and 5-year)
- Changes in right ventricular dimensions and function(30-day, 1-year and 5-year)
- All-cause death(5-year)
- Changes in liver and kidney function(30-day, 1-year and 5-year)
- Changes in tricuspid regurgitation degree(30-day, 1-year and 5-year)
- Changes in NYHA class(30-day, 1-year and 5-year)
- Cardiovascular death or heart failure hospitalization(5-year)
研究者
Marianna Adamo
Principal investigator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.Tricuspid Valve DiseaseHeart FailureNCT06458907P+F Products + Features USA Inc.780
已完成
不适用
TRICUS STUDY - Safety and Efficacy of the TricValve® DeviceSevere Tricuspid RegurgitationNCT03723239P+F Products + Features GmbH9
进行中（未招募）
不适用
TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)Tricuspid Valve DiseaseTricuspid RegurgitationNCT06137807P+F Products + Features USA Inc.50
已完成
不适用
Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Magnetic Resonance ImagingTricuspid Valve InsufficiencyNCT04522154Heart and Diabetes Center North-Rhine Westfalia30
招募中
不适用
German Registry for Transcatheter Tricuspid Valve InterventionsTricuspid Valve InsufficiencyHeart ValveTricuspid RegurgitationNCT04653428LMU Klinikum600