Randomized, Multi-Center, Event-Driven Trial of TAVI Versus SAVR in Patients With Symptomatic Severe Aortic Valve Stenosis and Intermediate Risk of Mortality, as Assessed by STS-Score - DEDICATE
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,414
- 试验地点
- 51
- 主要终点
- Freedom from stroke or death
研究概览
简要总结
Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality in a 1:1 fashion to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) to test, whether TAVI is non-inferior to SAVR, as measured by all-cause mortality or stroke after 1 and 5 years.
详细描述
A paradigm-shift towards performing TAVI in intermediate- and low-risk patients has already begun, as procedural results of TAVI have improved significantly within the past years. Nevertheless, a prospective and independent comparison of surgical (SAVR) and interventional (TAVI) valve therapy in patients considered at low to intermediate risk that covers an "all-comers" patient population and multiple devices has not yet been performed.
The DEDICATE-trial is designed as a prospectively randomized (1:1), multi-center, comparator-controlled interventional trial to investigate whether transcatheter aortic valve implantation (TAVI) is non-inferior - as measured by all-cause mortality or stroke after 1 and 5 years - compared to surgical aortic valve replacement (SAVR) in the treatment of patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality, as assessed by the local Heart Team.
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
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart team consensus that TAVI and SAVR are both medically justified and advisable based on:
- •Degenerative aortic valve stenosis with echocardiographically derived criteria:
- •Mean gradient >40 mmHg or
- •Jet velocity greater than 4.0 m/s or
- •Aortic valve area (AVA) of < 1.0 cm2 (indexed effective orifice area < 0.6cm2/m2).
- •Patient is symptomatic from his/her aortic valve stenosis
- •New York Heart Association Functional Class ≥ II or
- •Angina pectoris or
- •Patient is classified as low to intermediate operative risk as assessed by the local heart team according to the variables outlined in the 2017 ESC/EACTS Guidelines for the Management of valvular heart disease, taking into account cardiac and extracardiac Patient characteristics and established risk scores (e.g. STS-PROM, EuroSCORE).
- •A transfemoral or alternative (e.g. transapical, transaortic, transaxillary) access for TAVI seems feasible. Centers should follow a "transfemoral first" strategy for the primary route of access; however, other routes of access are also allowed, as decided by local heart team consensus.
- •Patient has provided written informed consent to participate in the trial.
- •Ability of the patient to understand the patient information and to personally sign and date the informed consent to participate in the study, before performing any study related procedures.
- •The patient agrees to undergo SAVR, if randomized to control treatment.
- •The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.
- •Patients aged 65 to 85 years.
- •Male patients or females who are postmenopausal defined as no menses for 12 months without an alternative medical cause.
排除标准
- •Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
- •Untreated clinically significant coronary artery disease considered a contraindication to an isolated aortic valve procedure (TAVI or SAVR) according to heart team consensus
- •Previous cardiac surgery
- •Any percutaneous coronary intervention performed within 1 month prior to the study procedure
- •Untreated severe mitral or tricuspid regurgitation
- •Untreated severe mitral stenosis
- •Hemodynamic instability requiring inotropic support or mechanical circulatory support
- •Ischemic stroke or intracranial bleeding within 1 month
- •Severe ventricular dysfunction with left ventricular ejection fraction < 20% as measured by resting echocardiogram
- •Hypertrophic obstructive cardiomyopathy or severe basal septal hypertrophy with outflow gradient
- •Echocardiographic evidence of an intracardiac mass, thrombus, vegetation or endocarditis
- •Any other condition considered a contraindication for an isolated aortic valve procedure
- •Symptomatic carotid or vertebral artery disease
- •Expected life expectancy < 12 months due to associated non-cardiac comorbidities
- •Currently participating in another investigational drug or device trial
研究组 & 干预措施
Surgical aortic valve replacement
Surgical aortic valve replacement (SAVR) with free choice of surgical bioprosthesis and free choice of surgical access according to the surgeon's preference.
干预措施: Surgical aortic valve replacement (Procedure)
Transcatheter aortic valve implantation
Transcatheter aortic valve implantation (TAVI) using the most appropriate CE (Conformité Européene)-marked device available, with a minimum demand of experience of 30 implanted devices/type per center.
干预措施: Transcatheter aortic valve implantation (Device)
结局指标
主要结局
Freedom from stroke or death
时间窗: within 1 year after randomization
(Safety endpoint)
次要结局
- Freedom from cardiovascular mortality(Five years after last patient in)
- Freedom from stroke(Five years after last patient in)
- Freedom from acute kidney injury(Five years after last patient in)
- Freedom from the composite of all-cause mortality and stroke(Five years after last patient in)
- Freedom from vascular access site and access-related complications(Five years after last patient in)
- Freedom from residual aortic regurgitation ≥ moderate(Five years after last patient in)
- Freedom from stroke or death(Five years after last patient in)
- Overall survival(Five years after last patient in)
- Freedom from myocardial infarction(Five years after last patient in)
- Freedom from major or life-threatening / disabling bleeding(Five years after last patient in)
- Freedom from conduction disturbances and arrhythmias, need for permanent pacemaker implantation(Five years after last patient in)
- Composite device success(Five years after last patient in)
- Composite clinical efficacy(within first 30 days after procedure)
- Freedom from prosthetic aortic valve endocarditis(Five years after last patient in)
- Freedom from the composite time-related valve safety(Five years after last patient in)
- Number of (re) hospitalisations(Five years after last patient in)
- Composite early safety(within first 30 days after procedure)
- Freedom from prosthetic valve dysfunction(Five years after last patient in)
- Health economic analysis(Five years after last patient in)
- Quality of life measures(Five years after last patient in)