Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment: the TRIPLACE Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 52
- 主要终点
- Freedom from device-related complications
研究概览
简要总结
The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the timing and onset of conduction disturbances necessitating permanent pacemaker implantation, and how such patients are managed. On this background, the TRIPLACE Registry - an investigator-initiated global multicenter registry - is aimed at better understanding the safety and efficacy of orthotopic TTVR.
详细描述
The primary aims of the registry will be:
- To examine the safety, efficacy, and long-term outcomes of TTVR
- To assess the incidence of procedural complications and their correlations with adverse clinical outcomes
- To investigate the impact of different pre/post-procedural factors on peri-procedural complications and long-term outcomes after TTVR
- To explore the characteristics of patients deemed eligible for TTVR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing Transcatheter Tricuspid Valve Replacement
- •Native Tricuspid Valve disease
- •Orthotopic Tricuspid Valve Implantation
排除标准
- •Age under 18 years
研究组 & 干预措施
Patients with Tricuspid Regurgitation undergoing Transcatheter Tricuspid Valve Replacement
Patients having clinically significant tricuspid regurgitation, defined according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease, requiring transcatheter tricuspid valve replacement
干预措施: Transcatheter Tricuspid Valve Replacement (Device)
结局指标
主要结局
Freedom from device-related complications
时间窗: 30 days after the index procedure
Freedom from device-related complications will be determined by assessing the number of participants with procedural, peri-procedural and device-related complications
Reduction in Tricuspid Regurgitation Severity
时间窗: 30 days after the index procedure
Tricuspid Regurgitation measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Tricuspid Regurgitation is measured by transthoracic echocardiography in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Change from baseline tricuspid regurgitation severity score 30 days after baseline will be assessed
次要结局
- All-cause mortality(12 months after the index procedure)
- Tricuspid Valve Reintervention(12 months after the index procedure)
- Combined all-cause mortality or rehospitalization for congestive heart failure(12 months after the index procedure)
- Hospitalization for congestive heart failure(12 months after the index procedure)
- The number of participants with New York Heart Association (NYHA) Stage III or IV heart failure(12 months after the index procedure)
- Permanent Pacemaker Implantation(30 days after the index procedure)
- Device Thrombosis(12 months after the index procedure)
- Tricuspid Regurgitation Severity(12 months after the index procedure)
- Quality of Life - Kansas City Cardiomyopathy Questionnaire(12 months after the index procedure)