PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 12
- 主要终点
- VARC-3 technical success
研究概览
简要总结
The goal of this registry is to learn how the Medtronic Evolut™ FX+ transcatheter aortic valve implantation (TAVI) System performs in adults with severe, symptomatic aortic stenosis who need valve replacement.
The main questions it aims to answer are:
- Can using a standardized procedure for the impantation of the Medtronic Evolut™ FX+ TAVI System increase safety and efficiency?
- What are the short-term (30 days) and long-term (1 year) patient outcomes, including the need for a pacemaker, complications, and valve function?
Participants will undergo TAVI with the Medtronic Evolut™ FX+ TAVI System as part of their routine care.
Be followed during their hospital stay, at 30 days, and at 1 year to check heart health, valve function, and recovery. 500 people at 12 hospitals in Portugal will take part in this registry.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects more than 18 years old, able to provide an Informed Consent:
- •Severe symptomatic (defined as New York Heart Association (NYHA) class ≥ II) aortic stenosis (AS), including but not limited to: Dyspnea at rest or on exertion, fatigue, angina, syncope in the absence of another identifiable cause;
- •Subjects provided written Informed Consent as approved by the Ethics Committee (EC);
排除标准
- •Subjects with pre-existing surgical bioprosthetic aortic valve;
- •Hepatic insufficiency (Child-Pugh Class B or C);
- •Contraindicated for treatment with the Medtronic Evolut™ FX+ TAVU System in accordance with the Instructions for Use (IFU);
- •Anatomically considered not suitable for the Medtronic Evolut™ FX+ TAVI system;
- •Subjects are currently participating in another clinical investigation that may confound the results of this Registry;
- •Subjects have an expected survival less than one year.
研究组 & 干预措施
Patients with severe aortic stenosis undergoing Medtronic Evolut FX+ TAVI System
Subjects with severe, symptomatic aortic stenosis (AS) with indication for TAVI (Transcatheter Aortic Valve Implant) with the Medtronic Evolut™ FX+ TAVI System - registry of routine practice.
结局指标
主要结局
VARC-3 technical success
时间窗: Immediately after the index procedure
A composite outcome assessed immediately after the TAVI procedure, including: survival, successful vascular access and device deployment/retrieval, correct positioning of a single valve, and freedom from major complications or need for surgery/intervention (excluding pacemaker).
次要结局
- Rate of Permanent Pacemaker Implantation (PPI)(30 days after procedure)
- Length of Hospital Stay(Up to 30 days after procedure)
- All-Cause Mortality(30 days and 1 year)
- Stroke(30 days and 1 year)
- Life-Threatening Bleeding(30 days and 1 year)
- Acute Kidney Injury(30 days and 1 year)
- Coronary Artery Obstruction(30 days and 1 year)
- Major Vascular Complications(30 days and 1 year)
- Valve Dysfunction Requiring Reintervention(30 days and 1 year)
- Rehospitalization(30 days and 1 year)
- Prosthetic Valve Function(30 days and 1 year)