NCT07398911Enrolling By Invitation不适用
3-Dimensional Simulation Guided Transcatheter Aortic Valve Replacement in Aortic Regurgitation(DIGITAL)
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2025年7月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Coaxial ratio of prosthetic aortic valve
研究概览
简要总结
This study will evaluate the safety and efficacy of postmarket bioprosthetic aortic valve in patients with severe aortic regurgitation undergoing transapical transcatheter aortic valve replacement based on 3D simulation technology using a prospective, randomized controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of the following conditions must be met for inclusion:
- •Age ≥ 65 years;
- •Symptomatic severe native aortic regurgitation;
- •Aortic valve anatomy assessed by investigator as suitable for transcatheter aortic valve replacement ;
- •Subjects signed a written informed consent and agreed to cooperate with all follow-up examinations.
排除标准
- •Patients meeting any of the following exclusion criteria were not included:
- •Active endocarditis;
- •Acute myocardial infarction or unstable angina pectoris, or severe coronary stenosis requiring coronary revascularization within 3 months;
- •Stroke or TIA (transient ischemic attack) within the past 3 months;
- •Any intracardiac mass, left ventricular or atrial thrombus, vegetation detected by echocardiography;
- •Severe obstructive hypertrophic cardiomyopathy (LVOTG peak ≥ 30 mmHg at rest); Note: Literature Basis: Chinese Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy 2023
- •History of bleeding tendency or coagulopathy or refusal of blood transfusion;
- •Active gastric ulcer or active gastrointestinal (GI) bleeding within 3 months;
- •Presence of contraindication to anticoagulation or antiplatelet;
- •Complicated with severe other valve diseases requiring concurrent surgical intervention;
- •Prior aortic valve graft (mechanical or bioprosthetic);
- •Severe left ventricular dysfunction, left ventricular ejection fraction < 30%;
- •Hepatic encephalopathy or acute active hepatitis;
- •Renal dysfunction (eGFR < 30ml/min calculated according to Cockcroft-Gault formula) and/or ongoing renal replacement therapy;
- •Patients with severe dementia and other poor compliance, unable to ensure the completion of the investigator;
- •Emergency surgery required for any reason;
- •Known hypersensitivity to contrast agents or nitinol memory alloys or porcine products;
- •Patients who are pregnant or plan to become pregnant, or are taking estrogen or estrogen-like drugs (women suspected of becoming pregnant must have a negative serum or urine test for human chorionic gonadotropin before being included in the study);
- •Other patients considered unsuitable for this clinical study by the investigator;
研究组 & 干预措施
Test group
Experimental
Using 3D simulation technique
干预措施: 3D simulation technique (Device)
Control group
No Intervention
Not using 3D simulation technique
结局指标
主要结局
Coaxial ratio of prosthetic aortic valve
时间窗: 12 months
Definition: A coaxial index of less than 4 degrees or a coaxial angle of less than 10 degrees is considered coaxial if one of them is met, and the ratio of coaxial prosthetic aortic valves in the two groups test group (with 3D simulation technique) or control group (without 3D simulation technique) is calculated, respectively Coaxial rate per group = number of coaxial aortic valve prostheses per group/total number of cases per group 100%
次要结局
- All-cause death, Disabling stroke, Myocardial infarction, and Heart failure(30 days)
- Technical success(immediate postoperative)
- All-cause mortality(30 days,12 months)
- Device success(30 days)
- Myocardial infarction(before discharge, 30 days, 12 months)
- Incidence of coronary obstruction(before discharge)
- CT imaging changes(12 months)
- New York Heart Association Functional Classification(before discharge, 30 days , 12 months)
- Evaluation cardiac function by electrocardiography(30 days,12 months)
- Evaluation of bioprosthesis performance by echocardiography(30 days,12 months)
- Contents of evaluation: including valve displacement, valve embolism and ectopic valve deployment(immediate postoperative)
- Major Cardiac Structural Complications(before discharge, 30 days)
研究者
Jian Yang
Chief Physician
Xijing Hospital
研究点 (1)
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