Treatment of Critical Aortic Valve Stenosis Using a Novel Valvuloplasty Scoring Balloon Catheter: a First-in-Man Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Procedural Success
研究概览
简要总结
The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of critical aortic valve stenosis.
详细描述
Phase 1 will enroll patient who are scheduled to undergo open surgical aortic valve replacement and will have the Valvuloplasty Scoring Balloon delivered to their stenotic aortic valve through a standard aortotomy and deployed immediately prior to valve replacement.
Phase 2 will enroll patients with aortic valve stenosis who are deemed to not be suitable candidates for elective surgical aortic valve replacement and in whom the investigational Valvuloplasty Scoring Balloon will be used as a stand-alone Valvuloplasty procedure or "bridge" to trans-catheter aortic valve implantation (TAVI) or surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Native, degenerative-calcific, tricuspid, aortic valve stenosis with echocardiographic derived criteria: mean gradient of >40 mm Hg or Doppler peak systolic velocity greater than 4.0 m/s or an initial aortic valve area < 0.8 cm
- •Symptomatic aortic valve disease as demonstrated by CCS Functional Class II or greater
- •Aortic valve annulus of greater than or equal to 18 mm and less than or equal to 28 mm measured on pre-procedure TTE.
- •Phase 1 patients must be scheduled for a surgical aortic valve replacement.
- •Phase 2 patients must not be suitable candidates for elective surgical aortic valve replacement.
排除标准
- •Recent myocardial infarction (<30days)
- •Unicuspid or bicuspid aortic valve or non-calcific aortic valve stenosis
- •Any sepsis, including active endocarditis
- •Concomitant 2+ or greater aortic valve valve regurgitation
- •LVEF < 20%
- •CVA or TIA within the previous 6 months
- •Previous aortic valve replacement (bioprosthetic or mechanical)
研究组 & 干预措施
AngioScore's Valvuloplasty Scoring Balloon
干预措施: AngioScore's Valvuloplasty Scoring Balloon (Device)
结局指标
主要结局
Procedural Success
时间窗: 1 day
Procedural success defined as a \>50% increase in the aortic valve effective orifice area and less than or equal to 2+ valvular regurgitation at the end of the percutaneous valvuloplasty procedure utilizing echocardiography, hemodynamic measurements and angiography.
Number of participants who do not experience death, stroke, myocardial infarction or emergency cardiac surgery during their hospitalization.
时间窗: Participants will be followed for the duration of the hospital stay, an expected average of 48 hours
Freedom from in-hospital death, stroke, myocardial infarction or emergency cardiac surgery
次要结局
未报告次要终点