A First in Human Study to Assess Safety and Performance of the DaVingi™ System in the Treatment of Patients With Functional Tricuspid Regurgitation
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Safety- the incidence and severity of device-related serious adverse device effects (SADE)
研究概览
简要总结
The DaVingi™ System is a percutaneous trans-catheter device delivered using right heart catheterization through the right internal jugular vein. The DaVingi™ System is designed for performing ring annuloplasty by using a Ring Delivery System to place a complete, flexible fabric ring around the annulus of the atrial side of the tricuspid valve. Fluoroscopy and echocardiography are used to monitor the ring placement procedure.
详细描述
The annuloplasty ring is a small multi-element ring, consisting of an outer fabric layer, a pre-set stakes array and internal adjustment cord that can be adjusted at a later stage after the outer layer of the ring and stakes are encapsulated in new tissue growth. Once implanted, the ring is designed to serve as a foundation for promoting new annular tissue growth, effectively growing a new adjustable annulus around the valve.
the study has been approved by Institutional Review Boards and Competent Authorities in Czech Republic, France and Israel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Severe tricuspid regurgitation as defined by American Society of Echocardiography.
- •Symptoms of right ventricular failure despite appropriate medical therapy.
- •Multidisciplinary heart team (minimum of three physicians, including cardiology and cardiac surgery representatives) recommends tricuspid annuloplasty.
- •≥18 years old at time of enrollment.
- •LVEF ≥ 30% within 45 days prior to index implant procedure.
- •PASP < 70 mmHg via right heart catheterization (subject at rest) within 90 days prior to index implant procedure.
- •Right Ventricle TAPSE ≥ 13 mm within 45 days prior to index implant procedure.
- •Tricuspid valve annular diameter ≥ 40 mm as measured by baseline transthoracic echocardiography in the 4 chamber view within 45 days prior to index implant procedure.
- •Subject has provided written informed consent.
- •Subject agrees to comply with all required post-procedure follow-up visits, including device adjustment.
排除标准
- •Acutely decompensated heart failure (i.e. hemodynamically unstable or on IV inotropes).
- •Severe Right Ventricle dysfunction.
- •Primary tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
- •Previous tricuspid valve repair or replacement.
- •Transvalvular pacemaker or defibrillator lead is present.
- •Severe left-sided valve disease.
- •Right-sided intra-cardiac mass, thrombus or vegetation is present.
- •Inability to properly guide the index implant procedure using Trans-esophagus echocardiography (e.g. acoustic window not adequate).
- •Subject requires chronic dialysis or renal replacement therapy.
- •MI or known unstable angina within the 30-days prior to the implant index procedure.
- •CVA within 3 months prior to index implant procedure.
- •Bleeding disorders, active peptic ulcer or GI bleed.
- •Contraindication to anticoagulation or antiplatelet medication, based on investigator's opinion.
- •Chronic oral steroid or immunomodulator use (≥ 6 months) or other condition that could impair healing response (e.g. cardiac sarcoidosis or other chronic inflammatory disease).
- •Any condition that, in the opinion of the investigator, may render the subject unable to complete the study (life expectancy < 1 year), or lead to difficulties for subject compliance with study requirements.
- •Subject is enrolled in another investigational study which has not completed the required primary endpoint follow-up period (Note: patients involved in a long-term surveillance phase of another study are eligible for this study).
- •Female patients who are pregnant or lactating.
研究组 & 干预措施
DaVingiTR System Single Arm
single-arm, open label, multi-center study.
干预措施: DaVingiTR System (Device)
结局指标
主要结局
Safety- the incidence and severity of device-related serious adverse device effects (SADE)
时间窗: from time of index implant/ adjustment procedure through 30 days post-implant
the incidence and severity of device-related serious adverse device effects (SADE) from time of index implant/ adjustment procedure through 30 days post-implant
Device performance - Adjustment Device Technical Success: Rate of successful adjustment of the DaVingi™ TR ring at the tricuspid annulus, desired by physician
时间窗: Immediately after procedure
Implant Device Technical Success and Adjustment Device Technical Success
次要结局
- safety - Incidence of device-related major adverse cardiac events (MACE)(30 days post procedure)
- safety - Rate of procedure-related serious adverse events (SAE)(30 days post procedure)