First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Technical success: Percentage of participants with successful access, delivery and retrieval of the TRICENTO G2 Delivery System AND successful deployment and correct positioning of the TRICENTO G2 Bioprosthesis measured via echocardiography
研究概览
简要总结
The goal of this clinical trial is to assess if the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTO G2 TVSTR) is safe and efficient in treating severe tricuspid regurgitation in adult patients.
The main questions it aims to answer are:
- Does the treatment with the TRICENTO G2 TVSTR improve symptoms of severe tricuspid regurgitation?
- Is the treatment with the TRICENTO G2 TVSTR safe?
Participants will:
- Undergo a minimally invasive procedure for the implantation of the TRICENTO G2 Bioprosthesis using the TRICENTO G2 Delivery System
- Visit the clinic for a baseline visit, the procedure itself, 30 days, 3 months, 6 months and 1 year after the procedure
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
- •Patients with symptomatic tricuspid regurgitation (TR), graded as severe or greater (accord. to TR 5-Tier Grading System TVARC)
- •Patients with TR leading to NYHA class II, III or IV or clinical signs of right heart failure
- •Patients suitable for implantation of the TRICENTO G2 Bioprosthesis according to anatomical and clinical criteria assessed by computed tomography, echocardiography and/or right heart catheterization (confirmed by a heart team)
- •Patients receiving optimal medical treatment for underlying diseases
- •Patients being able to give informed consent
- •Patients empowered and willing to comply with the study procedures
排除标准
- •Superior vena cava diameter < 22.9 mm or > 37.1 mm (perimeter derived)
- •Inferior vena cava diameter < 27.9 mm or > 42.9 mm (perimeter derived)
- •Right atrium cavity height < 55 mm or > 80 mm (direct path between caval ostia)
- •Peak right atrial pressure > 50 mmHg
- •Systolic pulmonary artery pressure (sPAP) > 60 mmHg
- •Pulmonary Vascular Resistance > 3 Wood units
- •Vascular conditions that do not allow for insertion and access routing of the 26 Fr Delivery System to the intended implantation site
- •Known hypersensitivity, allergy or contraindication to the device's materials, e.g. Nitinol
- •Echocardiographic evidence of intra-cardiac thrombus or vegetation
- •Relevant tricuspid valve stenosis (e.g. determined by a mean diastolic transvalvular gradient > 5 mmHg at a normal heart rate)
- •RV dysfunction determined by multiple of the following
- •TAPSE < 10mm
- •RVOT VTI < 10 cm
- •TASV/S' < 11.5 cm/s
- •RV FAC < 30 %
- •RV EF < 35 %
- •Severe uncontrolled hypertension (systolic BP ≥ 180 mmHg and/or diastolic BP ≥ 110 mmHg)
- •LV function defined by LVEFbp < 25 %
- •Indication for intervention for any of the other heart valves or for open cardiac surgery
- •Any PCI or transcatheter valvular intervention within 30 days prior to the index procedure or planned 3 months post the index procedure
- •Myocardial infarction within the 30 days prior to the index procedure
- •Evidence of a present thrombosis of the lower venous system
- •Medical devices present in the intended implantation site that are expected to interfere with the access, proper deployment and/or function of the prosthesis
- •Evidence of active endocarditis or other acute infections
- •Known hypersensitivity or contraindication to anticoagulation, anti-platelet medication, or contrast media, which cannot be adequately pre-medicated
- •Patients on chronic dialysis
- •Thrombophilia
- •Bleeding diathesis or coagulopathy
- •Women of childbearing potential, defined as females who have experienced menarche and who are not permanently sterile or not postmenopausal (≥12 consecutive months without menses without an alternative medical cause)
- •Patients with any known life-threating, non-cardiac disease that will limit life expectancy of the patient to less than one year
研究组 & 干预措施
Investigational device (TRICENTO G2 TVSTR)
Since the study is a single-arm study, there is only one study arm that is treated with the investigational device. The participants are treated with the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTO G2 TVSTR).
干预措施: TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR) (Device)
结局指标
主要结局
Technical success: Percentage of participants with successful access, delivery and retrieval of the TRICENTO G2 Delivery System AND successful deployment and correct positioning of the TRICENTO G2 Bioprosthesis measured via echocardiography
时间窗: immediately at the end of procedure
Technical success \[given as percentage of participants\] 1. Successful access, tracking and withdrawal of the TRICENTO G2 Delivery System \[Yes/No\] 2. Successful deployment and correct positioning of the TRICENTO G2 Bioprosthesis \[Yes/No\]
Frequency and composite of device-related or procedure-related serious adverse events (SAEs)
时间窗: during and immediately after the procedure, at discharge (latest 7 days post-implantation), 30 days post-implantation
With SAE classification according to MDR and MDCG 2020-10.
Frequency of device deficiencies
时间窗: during and immediately after the procedure, at discharge (latest 7 days post-implantation), 30 days post-implantation
Device deficiency: Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance.
Rate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure
时间窗: during and immediately after the procedure, at discharge (latest 7 days post-implantation), 30 days post-implantation
次要结局
- Clinical performance and functionality of the TRICENTO G2 Bioprothesis assessed via echocardiography(immediately at the end of the procedure, at discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, 12 months post-implantation)
- Clinical performance and functionality of the TRICENTO G2 Bioprothesis assessed via right heart catheterization(immediately at the end of the procedure, 6 months post-implantation)
- Clinical performance and functionality: Assessment of device position(6 months post-implantation)
- Clinical performance and functionality: Assessment of stent geometry(6 months post-implantation)
- Clinical performance and functionality: Assessment of inflow and outflow patency of the Bioprosthesis(6 months post-implantation)
- Clinical performance and functionality: Assessment of anatomical interaction and tissue response(6 months post-implantation)
- Clinical benefit: Changes in the presence and severity of lower-extremity edema according to Edema severity score(at baseline, 30 days, 3 months, 6 months and 12 months post-implantation)
- Clinical benefit: Changes in the severity of heart-failure symptoms according to NYHA classification(at baseline, 30 days, 3 months, 6 months and 12 months post-implantation)
- Clinical benefit: Changes in the functional exercise capacity assessed via 6 Minute Walk Test(at baseline, 30 days, 3 months, 6 months and 12 months post-implantation)
- Clinical benefit: Changes in particpants' quality of life determined via Kansas City Cardiomyopathy Questionnaire(at baseline, 30 days, 3 months, 6 months and 12 months post-implantation)
- Clinical benefit: Rate of hospitalizations for heart failure (HF)(12 months post-implantation)
- Frequency and composite of device-related or procedure-related serious adverse events (SAEs)(3 months, 6 months and 12 months post-implantation)
- Frequency of device deficiencies(3 months, 6 months and 12 months post-implantation)
- Rate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure(3 months, 6 months and 12 months post-implantation)