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临床试验/NCT05082337
NCT05082337已完成不适用

The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures: A Feasibility Study

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
4
主要终点
Presence of Major vascular complications

研究概览

简要总结

TAVR patients exhibiting post-procedural residual AR had higher mortality and hospitalization rates due to heart failure, with the extent of this association increasing proportionally to the severity of the regurgitation. Optimizing transcatheter valve performance by intra-procedural hemodynamic evaluation of AR and residual transvalvular gradient remains of high clinical importance.

详细描述

Continuous technological development and procedural refinements are important to further reduce TAVR peri-procedural complications, facilitate the minimalist strategy and improve clinical outcomes following TAVR. Residual aortic regurgitation (AR) has been one of the main drawbacks of TAVR. TAVR patients exhibiting post-procedural residual AR had higher mortality and hospitalization rates due to heart failure, with the extent of this association increasing proportionally to the severity of the regurgitation.

Various actions could be undertaken to minimize AR and its consequences, either intraprocedural (balloon post-dilation, implantation of a second valve) or during follow-up (diuretic treatment, closest clinical follow-up or percutaneous leakage closure). Thus, an accurate diagnosis of the presence and severity of residual AR post-TAVR is key to implement the proper measures and optimize clinical outcomes.

The use of cardiac imaging remains the gold standard for evaluating AR post-TAVR, limitations of contrast amount along with the subjectivity of AR evaluation by aortic angiography, and the challenges of echocardiography at the time of the TAVR procedure represent a significant drawback. Thus, alternative tools for evaluating the presence and severity of AR would be very helpful in this setting.

Current data supports the implementation of hemodynamic measurements during TAVR procedures in order to improve the clinical decision-making process following valve implantation. However, these actions entail an inherent risk associated with the exchange of catheter-wires. The use of a support guidewire with pressure measurement capabilities would facilitate the hemodynamic evaluation of transcatheter valve performance in a safer and more rapid manner.

The new SAVVY guidewire, with both dedicated pacing properties and allowing a continuous hemodynamic pressure monitoring during the procedure, is a unique system in the field and may represent an important step forward in the process of optimizing the TAVR procedure while facilitating procedural steps.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Patients with severe symptomatic AS undergoing a TAVR procedure.

排除标准

  • Failure to provide signed informed consent.
  • Extremely calcified aortic valve (Agatston score >3000 AU)
  • Extremely horizontal aorta.
  • Severe septal hypertrophy (interventricular septum >15 mm as measured by TTE).
  • Extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta.
  • Prohibitive surgical risk precluding (according to the Heart Team) conversion to open heart surgery in case of a life threatening complication.
  • Young patients (<18 Years) and pregnant women

结局指标

主要结局

Presence of Major vascular complications

时间窗: Periprocedural

Major vascular complications related to the SAVVY guidewire are defined as stroke, bleeding or left ventricular perforation

Number of transcatheter valve malpositioning

时间窗: Periprocedural

Pacing capture failure translating into valve malpositioning. Valve malpositiong will be evaluated by a landing site to low or too high, leading to hemodynamically unfavorable results.

Presence of Major complications

时间窗: Periprocedural

Presence of major complications related to the SAVVY guidewire including (i) guidewire kink hindering or preventing the advancement of the transcatheter valve system

Number of valve embolization

时间窗: Periprocedural

Pacing capture failure translating into valve embolization

Number of effective rapid pacing run

时间窗: Periprocedural

Effective rapid pacing will be defined as an adequate ventricular pacing capture for a minimum of 10 seconds, with no capture loss, and leading to a reduction of aortic pressure of at least 50%, with/or a systolic pressure value \<60 mmHg. Efficacy will be assessed by the physician.

Number of accurate ventricular pressure

时间窗: Periprocedural

Accurate ventricular pressure will be defines as a pressure wire measurements similar (differences \<5 mmHg) to those obtained simultaneously with a pigtail catheter in the same cavity or vascular segment (differences \<5 mmHg in SBP, differences \<5 mmHg in LVEDP).

次要结局

未报告次要终点

研究者

发起方
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
申办方类型
Other
责任方
Principal Investigator
主要研究者

Josep Rodes-Cabau

Principal investigator

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

研究点 (4)

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