Safety and Feasibility of Transradial Mini-invasive Balloon Aortic Valvuloplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 361
- 试验地点
- 17
- 主要终点
- Vascular complications
研究概览
简要总结
The spreading of transcatheter aortic valve implantation has paradoxically increased the spectrum of indications for balloon aortic valvuloplasty. Balloon aortic valvuloplasty is currently used as destination therapy for patients excluded from transcatheter aortic valve implantation, as bridge to transcatheter aortic valve implantation or to surgical aortic valve replacement, or as a stratification tool for selected high-risk patients who cannot be immediate candidates for transcatheter aortic valve implantation. Moreover, it has been recently showed that transcatheter aortic valve implantation without balloon aortic valvuloplasty is encumbered by an increased risk of cerebral embolization. However, balloon aortic valvuloplasty has a complication rate comparable to transcatheter aortic valve implantation, mainly related to access site or temporary pacemaker implantation. Thus, a transradial mini-invasive approach with rapid pacing through the 0,035 inch left ventricular support wire could be extremely appealing.
详细描述
Consecutive patients with severe aortic stenosis with indication to aortic balloon valvuloplasty will be enrolled. An ad hoc informed consent for the procedure will be obtained from all patients.
This is a prospective observational study. The Investigators will include patients where aortic ballloon valvuloplasty is attempted by radial access and without temporary pacemaker implantation. The aim is to register and monitor the effectiveness and safety of this approach. Details regarding management of radial access and pacing with 0.035 wire can be found in the references reported below. The primary endpoint will be the 30-day occurence of minor and major vascular complications according VARC 2 classification. The safety endpoint will be the absence of intra- or periprocedural major complications in transradial balloon aortic valvuloplasty, namely balloon entrapment or compartment syndrome requiring surgical intervention.
The feasibility endpoint will be a procedural success rate ≥90%. The efficacy endpoint will be a reduction of the mean invasive gradient >30%. At baseline, Handgrip strength test will be performed and angiography of the instrumented arm will be performed at the beginning and at the end of the procedure. All patients will be prospectively followed-up for at least 30 days and all adverse events will be recorded. All patients will be assessed also for frailty according the clinical frailty scale (CFS). During the 30-day follow-up visit two independent blinded operators will evaluate radial artery patency by ultrasonography and perform handgrip strength test in in both arms in all patients.
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
- •severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty
排除标准
- •cardiogenic shock
- •bilateral absence of radial pulse
结局指标
主要结局
Vascular complications
时间窗: 1 month
Cumulative occurrence of major and minor bleeding complications according the VARC-2 classification
次要结局
- Major vascular complications(1 month)
- Minor vascular complications(1 month)
- Transradial balloon aortic valvuloplasty major complications(1 month)
- Radial artery occlusion(24 hours)
- Adverse events(1 month)
研究者
Gianluca Campo
Associate Professor
University Hospital of Ferrara