Studio OsseRvaziOnAle RelatIvo Al Follow-up a LuNGo Termine Di Pazienti Con Stenosi Aortica Severa Valutati Per Sostituzione Valvolare Aortica Percutanea (TAVI).
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Prosthesis failure
研究概览
简要总结
All patients with severe aortic stenosis undergoing evaluation for TAVI are routinely subjected to a series of assessments:
- Pre-implantation: thoraco-abdominal CT angiography, coronary angiography, echocardiography, clinical assessment, ECG, and laboratory tests.
- Post-implantation: echocardiography, laboratory tests, ECG, assessment of any procedural complications, and a cardiology follow-up visit.
This is an observational study, with the aim to monitor over time the population of patients who have undergone TAVI, identifying pre- and post-implant conditions that may negatively impact patient outcomes (both clinical factors and those directly related to the prosthetic implant). Through a 10-year follow-up, the study seeks to determine the incidence of prosthetic failure, as well as the incidence of prosthesis-related complications and major clinical endpoints.
详细描述
DESIGN OF THE STUDY
This is a retrospective and prospective observational, non-profit study. All consecutive patients who have entered the TAVI pathway at this hospital (Azienda Ospedaliera Universitaria di Ferrara) since January 2016 will be included in the study.
The study does not involve any alteration or modification of routine clinical practice and does not require any center or operator to use specific devices.
It involves the collection of pre- and post-procedural data from patients who enter the TAVI pathway.
All patients will be re-contacted to confirm clinical follow-up via telephone to gather information on any adverse events that may have occurred in the years following TAVI (at 1, 5, and 10 years post-TAVI).
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
- •Age >18 years Signing of the consent form Diagnosis of severe aortic stenosis with an indication for TAVI Completion of the required TAVI pathway exams (ECG and cardiology consultation, echocardiogram, thoraco-abdominal aortic CT angiography, coronary angiography)
排除标准
- •Lack of signed consent form Inability to complete follow-up
结局指标
主要结局
Prosthesis failure
时间窗: 10 years
Valve-related mortality OR aortic valve reintervention OR Stage III hemodynamic valve deterioration.
次要结局
- composite of all-cause death, stroke and myocardial infarction(1, 5 and 10 years)
- all-cause death(1, 5 and 10 years)
- myocardial infarction(1, 5 and 10 years)
- stroke or transient ischemic attack(1, 5 and 10 years)
- atrial fibrillation(1, 5, 10 years)
- pacemaker implantation(1, 5 and 10 years)
- endocarditis(1, 5 and 10 years)
- re-hospitalization(1,5 and 10 years)
- prosthesis failure(1 and 5 years)
- single component of the primary endpoint(10 years)
- incidentalomas(1, 5 and 10 years)
- prosthesis failure in patients with incidentaloma(1 and 5 years)
- re-TAVI or SVAR in TAVI(5 and 10 years)
- coronary revascularization(1 and 5 years)
- complication after valvuloplasty pre-TAVI(in-hospital, 1 year)
- CT predictors of complications post valvuloplasty(1 year)
研究者
Rita Pavasini
Principal Investigator
University Hospital of Ferrara