Cerebral Regional Oxygen Saturation During TAVI: A Prospective Comparison of Balloon-Expandable and Self-Expanding Valves
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in cerebral regional oxygen saturation (rSO₂) during transcatheter aortic valve implantation (TAVI)
研究概览
简要总结
This single-center, non-commercial clinical study investigates how different types of transcatheter aortic valve prostheses affect cerebral oxygen saturation during the procedure (TAVI - Transcatheter Aortic Valve Implantation). The study uses a non-invasive monitoring system (NIRS) to track brain oxygenation (rSO₂) in real time.
The goal is to understand whether balloon-expandable, intra-annular self-expanding, or supra-annular self-expanding valves lead to different levels or patterns of cerebral oxygenation. This may help identify early warning signs for delayed hemodynamic recovery, stroke, or delirium.
Participants will be randomly assigned to receive one of:
A balloon-expandable valve (Group A), or
A self-expanding valve (Group B), with further randomization into:
Group B1: intra-annular valve (NAVITOR)
Group B2: supra-annular valve (EVOLUT)
The procedure, follow-up, and data collection will follow standard clinical practice. No experimental devices or drugs are used. Patients will not undergo any additional risk or burden beyond what is normally expected during TAVI.
The study is being conducted at the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy, and aims to enroll 40 patients. No compensation is provided, and participation is voluntary.
详细描述
This is a prospective, randomized, single-center, interventional clinical study conducted at the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy. The study aims to investigate differences in cerebral regional oxygen saturation (rSO₂) during transcatheter aortic valve implantation (TAVI) using different transcatheter heart valve (THV) technologies.
Aortic valve stenosis (AVS) is the most common valvular disease in the elderly, and TAVI has become a widely accepted therapeutic option in high-, intermediate-, and low-risk patients. However, the rapid ventricular pacing, balloon dilatation, and valve deployment involved in TAVI may induce transient cerebral hypoperfusion. This study utilizes near-infrared spectroscopy (NIRS) as a non-invasive method to monitor cerebral oxygenation in real-time during the procedure.
The primary objective is to evaluate the variation in rSO₂ during specific procedural phases and determine whether the type of valve used (balloon-expandable vs. self-expanding) impacts cerebral perfusion. A secondary aim is to identify a potential threshold value of rSO₂ below which prolonged hemodynamic recovery may occur. The study also explores the association between cerebral desaturation and clinical outcomes such as in-hospital mortality, stroke, and postprocedural delirium.
Patients with symptomatic severe aortic stenosis meeting specific inclusion/exclusion criteria will be enrolled and randomized 1:1 to receive:
Group A: A balloon-expandable valve (SAPIEN platform, Edwards Lifesciences)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study-specific procedures
- •Diagnosis of severe degenerative aortic valve stenosis with echocardiographic criteria:
- •Mean gradient > 40 mm Hg, or
- •Jet velocity > 4.0 m/s, or
- •Aortic valve area (AVA) < 0.8 cm² (or AVA index < 0.5 cm²/m²)
- •Symptomatic aortic stenosis defined as NYHA functional class ≥ II
排除标准
- •Symptomatic carotid artery disease or indication for carotid revascularization
- •Cardiogenic shock or inotropic support required prior to the procedure
- •Active neurodegenerative disease
- •Contraindications as determined by anesthesiology screening
- •Age < 18 years
- •Contraindications to NIRS monitoring
- •ST-elevation myocardial infarction or cardiogenic shock within 48h before enrollment
- •Emergency TAVI due to decompensated AV stenosis
- •Malignancy or comorbidities with life expectancy < 12 months
- •Inability to comply with the study protocol
- •Stroke or transient ischemic attack within 6 months
- •Renal insufficiency (creatinine > 3.0 mg/dL) or dialysis dependency
- •Severe left ventricular dysfunction (LVEF < 30%)
- •Significant mixed valvular disease (e.g., severe mitral or tricuspid regurgitation)
- •Intracardiac mass, thrombus, or vegetation
- •Chronic corticosteroid use
- •Participation in another investigational drug or device study
- •Active bacterial endocarditis or other active infections
结局指标
主要结局
Change in cerebral regional oxygen saturation (rSO₂) during transcatheter aortic valve implantation (TAVI)
时间窗: Intraoperative, from pre-induction to end of TAVI procedure (approximately 60-90 minutes)
Cerebral rSO₂ will be monitored at six procedural timepoints using NIRS: pre-induction, start of procedure, pre-dilatation (if performed), valve deployment, lowest rSO₂ value during deployment, post-dilatation (if performed), and end of procedure. The primary outcome is the comparison of rSO₂ profiles between patients receiving balloon-expandable valves and those receiving self-expanding valves.
次要结局
- Incidence of postoperative delirium(First 3 days after the procedure or until discharge from ICU)
- In-hospital all-cause mortality(From procedure to hospital discharge (up to 14 days))
- In-hospital stroke incidence(From procedure to hospital discharge (up to 14 days))