Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock - The TACTICS Study - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Days alive out of hospital
研究概览
简要总结
The goal of this clinical trial is to learn if acute transcatheter aortic valve implantation (TAVI) is superior to standard treatment (stabilization in an intensive care unit and TAVI subsequently) to treat cardiogenic shock in patients with critical severe aortic stenosis.
The main questions it aims to answer are:
• Does acute TAVI increase survival compared with standard treatment?
Participants will:
- Undergo either TAVI within 12 hours after admission or stabilization and TAVI 72 hours or more after admission
- Visit an outpatient clinic and be evaluated for quality of life and heart function
详细描述
Aortic stenosis (AS) is a condition where the heart's aortic valve narrows. With an estimated prevalence of 12% in individuals aged 75 years and above, it is the most common heart valve disease. The progressive narrowing increases the afterload on the heart, impairing its ability to maintain cardiac output. The end-stage of critical AS is cardiogenic shock (CS) with an incidence of 3.5% to 12%. Without treatment, patients develop acute decompensation, organ failure, and ultimately die.
Guidelines suggest balloon aortic valvuloplasty (BAV), hemodynamic optimization in the intensive care unit and surgical aortic valve replacement or transcatheter aortic valve implantation (TAVI) when the patient is stable. Even with BAV, the 30-day mortality is 33%-47% and a 1-year mortality is 70%. Further, the BAV procedure is associated with only a minor and likely temporary reduction in afterload due to elastic valvular tissue. Furthermore, the BAV procedure has been abandoned as a routine intervention in these patients due to a series of patients having limited immediate clinical response, a risk of deterioration and no impact on overall mortality risk. Moreover, most patients with critical AS in CS are not candidates for surgical aortic valve replacement because of increased peri-operative risk of morbidity and mortality.
Despite the recommendation on TAVI under stable conditions, an acute TAVI may be efficient in afterload reduction and more efficient than the limited and transient effects of BAV. TAVI has become an attractive alternative to surgery and BAV because of the less invasive nature of this procedure, yet permanent result (compared with BAV). It is already approved for the treatment of AS irrespective of CS status. This raises the question:
"Should acute TAVI be the new preferred treatment strategy in AS patients in Cardiogenic shock?"
In this randomized controlled trial, we will include patients with severe aortic stenosis and cardiogenic shock. Patients will undergo either acute TAVI or standard treatment (stabilization in a cardiac intensive care unit and subsequently TAVI) in a 1:1 ratio. Outcomes are evaluated 90 days after randomization and comprise days alive out of hospital, mortality, cardiac function, renal function, and quality of life.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aortic valve area less than 1cm2
- •Cardiogenic Shock defined as:
- •Peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol/l) AND
- •Systolic blood pressure < 100 mmHg and/or need for vasopressor therapy (dopamine/ norepinephrine or epinephrine) AND
- •Left ventricular ejection fraction ≤ 45%
- •- Syncope/resuscitation (mechanical ventilation)
排除标准
- •Intracranial hemorrhage < 1 month ago
- •Remaining life-expectancy < 6 month due to other cause
- •Body mass index <15 OR > 40
- •Clinical frailty score ≥6 before present worsening
- •Severe lung disease (forced expiratory volume in 1 second OR diffusion capacity of the lungs for carbon monoxide < 25 of expected)
- •Unsuitable for TAVI prior to screening
研究组 & 干预措施
Acute TAVI
Acute TAVI within 12 hours.
干预措施: Acute TAVI (Procedure)
Standard treatment
TAVI no earlier than 72 hours.
干预措施: Stabilization and subacute TAVI (Other)
结局指标
主要结局
Days alive out of hospital
时间窗: 90 days post-randomization
Days alive out of hospital
次要结局
- Mortality(90 days post-randomization)
- LVEF(90 days post-randomization)
- Clinical Frailty Scale(90 days post-randomization)
- EQ-5D-5L(90 days post-randomization)
- N-terminal-pro-brain- natriuretic peptide levels(90 days post-randomization)
- eGFR(90 days post-randomization.)
研究者
Emil Loldrup Fosbol
Professor
Rigshospitalet, Denmark