Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary performance endpoint
研究概览
简要总结
The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients affected by severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation
- •Full understanding and willing to provide informed consent to study enrolment
排除标准
- •Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
- •Refusal to provide informed consent to study enrolment
- •Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
- •Patients with calcification on the annulus and in the Left Ventricular Outflow Tract (LVOT), or/and excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator
结局指标
主要结局
Primary performance endpoint
时间窗: 30 days
Device success as defined by VARC-3, as composite of: * Technical success; * Freedom from mortality; * Freedom from surgery or intervention related to the device or to a major vascular or access related or cardiac structural complication; * Intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).
Primary safety endpoint
时间窗: 30 days
Early safety as defined by VARC-3, as composite of: * Freedom from all-cause mortality; * Freedom from all stroke; * Freedom from VARC 3 type 3-4 bleeding; * Freedom from major vascular, access-related, or cardiac structural complication; * Freedom from acute kidney injury stage 3 or 4; * Freedom from moderate or severe aortic regurgitation; * Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; * Freedom from surgery or intervention related to the device.
次要结局
- Disabling stroke(30 days, and 1-year)
- Major vascular complication(30 days)
- New permanent pacemaker implantation due to procedure related conduction abnormalities(30 days, and 1-year)
- Effective Orifice Area (EOA)(30 days, and 1-year)
- All-cause mortality(30 days, and 1-year)
- All stroke(30 days, and 1-year)
- Acute kidney injury(30 days)
- Myocardial infarction(30 days, and 1-year)
- Coronary artery obstruction requiring intervention(30 days, and 1-year)
- Mean aortic valve gradient(30 days, and 1-year)
- Technical success(Immediately after procedure)
- Cardiovascular mortality(30 days, and 1-year)
- Quality-of-life evaluation(30 days, and 1-year)
- Bioprosthetic valve dysfunction (BVD)(30 days, and 1-year)
- New-onset atrial fibrillation(30 days, and 1-year)
- Re-hospitalization for procedure- or valve-related causes(30 days, and 1-year)
- New York Heart Association (NYHA) functional class(30 days, and 1-year)
- Stroke or peripheral embolism(30 days, and 1-year)
- VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns(30 days, and 1-year)
- Commissural alignment(30 days)
- Paravalvular leak(30 days, and 1-year)
- Rates of Hypoattenuated Leaflet Thickening (HALT)(30 days)
- Bioprosthetic Valve Failure (BVF)(30 days, and 1-year)
- Rates of Reduced leaflet motion (RLM)(30 days)