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| Name | Class |
|---|---|
| LS medcap GmbH | OTHER |
| Clinical Accelerator | INDUSTRY |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational device (TRICENTO G2 TVSTR) | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR) | Device | The TRICENTO G2 TVSTR consists of a Bioprosthesis and a Delivery System including a Loading Funnel. The Bioprosthesis is an endovascular graft-like implant in combination with a lateral valve element. It is placed into the right atrium while spanning from inferior to superior vena cava leaving the native valve apparatus untouched (heterotopic approach). The TRICENTO G2 Bioprosthesis is designed to reduce the reflux of blood into the caval system during systole while allowing for forward flow during diastole. The TRICENTO G2 Bioprosthesis is delivered minimally invasive by transfemoral venous access using a catheter-based Delivery System. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Technical success [given as percentage of participants]
| immediately at the end of procedure |
| Frequency and composite of device-related or procedure-related serious adverse events (SAEs) | With SAE classification according to MDR and MDCG 2020-10. | during and immediately after the procedure, at discharge (latest 7 days post-implantation), 30 days post-implantation |
| Frequency of device deficiencies | Device deficiency: Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance. | during and immediately after the procedure, at discharge (latest 7 days post-implantation), 30 days post-implantation |
| Rate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure | during and immediately after the procedure, at discharge (latest 7 days post-implantation), 30 days post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance and functionality of the TRICENTO G2 Bioprothesis assessed via echocardiography | Assessment via echocardiography (TEE/TTE):
| immediately at the end of the procedure, at discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, 12 months post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Exploartory safety endpoint: Overall mortality | All deaths occurring during the clinical investigation. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in Tricuspid Regurgitation - Effective Regurgitant Orifice Area (TR EROA) |
Inclusion Criteria:
Exclusion Criteria:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Klink, M. Sc. | Contact | +49 (0) 151 14140423 | laura.klink@lsmedcap.com | |
| Natasa Mitrovic, M. Sc. | Contact | +49 (0) 151 14116755 | natasa.mitrovic@lsmedcap.com |
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Exploratory, interventional, single-arm, open-label, multicentre, prospective
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| Clinical performance and functionality of the TRICENTO G2 Bioprothesis assessed via right heart catheterization | Change in peak central venous pressure (CVP [mmHg]) or CVP pulsatility or differential pressure [mmHg] over the prosthetic valve right atrium-central venous system. | immediately at the end of the procedure, 6 months post-implantation |
| Clinical performance and functionality: Assessment of device position | Assessment of device position assessed via computed tomography (CT). | 6 months post-implantation |
| Clinical performance and functionality: Assessment of stent geometry | Assessment of stent geometry assessed via computed tomography (CT). | 6 months post-implantation |
| Clinical performance and functionality: Assessment of inflow and outflow patency of the Bioprosthesis | Assessment of inflow and outflow patency of the Bioprosthesis assessed via computed tomography (CT). | 6 months post-implantation |
| Clinical performance and functionality: Assessment of anatomical interaction and tissue response | Assessment of anatomical interaction and tissue response assessed via computed tomography (CT). | 6 months post-implantation |
| Clinical benefit: Changes in the presence and severity of lower-extremity edema according to Edema severity score | Grading 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 | 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 | Changes in participants' functional exercise capacity assessed based on the distance [m] covered during the 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 | The Kansas City Cardiomyopathy Questionnaire - 12 item version (KCCQ-12) will be used to assess patient-reported health status related to heart failure, providing a validated, efficient, and sensitive measure of disease-related quality of life. The minimum value is 0 and the maximum value is 100. A higher score means a better outcome. | at baseline, 30 days, 3 months, 6 months and 12 months post-implantation |
| Clinical benefit: Rate of hospitalizations for heart failure (HF) | Rate of hospitalizations for heart failure (HF) within 12 months after the index procedure; with a comparison of the rates for HF-related hospitalizations within 12 months prior to the index procedure and HF-related (re-)hospitalizations within 12 months after the index procedure | 12 months post-implantation |
| Frequency and composite of device-related or procedure-related serious adverse events (SAEs) | With SAE classification according to MDR and MDCG 2020-10. | 3 months, 6 months and 12 months post-implantation |
| Frequency of device deficiencies | Device deficiency: Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance. | 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 |
Imaging of cardiac structures via echocardiography, comparing TR EROA [mm^2] to baseline. |
| at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in TR regurgitant volume | Imaging of cardiac structures via echocardiography, comparing TR regurgitant volume [mL] to baseline. | at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in Tricuspid annular plane systolic excursion (TAPSE) | Imaging of cardiac structures via echocardiography, comparing TAPSE [mm] to baseline. | at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in Right Ventricular (RV) basal diameter | Imaging of cardiac structures via echocardiography, comparing RV basal diameter [mm] to baseline. | at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in RV mid diameter | Imaging of cardiac structures via echocardigraphy, comparing RV mid diameter [mm] to baseline. | at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in RV longitudinal diameter | Imaging of cardiac structures via echocardiography, comparing RV longitudinal diameter [mm] to baseline. | at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in RV end-diastolic area | Imaging of cardiac structures via echocardiography, comparing RV end-diastolic area [mm^2] to baseline. | at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in RV end-systolic area | Imaging of cardiac structures via echocardiography, comparing RV end-systolic area [mm^2] to baseline. | at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in Left Ventricular (LV) end-diastolic diameter | Imaging of cardiac structures via echocardiography, comparing LV end-diastolic diameter [mm] to baseline. | at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in Right atrial (RA) diameter | Imaging of cardiac structures via echocardiography, comparing RA diameter [mm] to baseline. | at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in RA area | Imaging of cardiac structures via echocardiography, comparing RA area [mm^2] to baseline. | at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in Left Ventricular Ejection Fraction (LVEF) | Imaging of cardiac structures via echocardiography, comparing LVEF [percentage] to baseline. | at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in Right Ventricular Fractional Area Change (RVFAC) | Imaging of cardiac structures via echocardiography, comparing RVFAC [percentage] to baseline. | at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in cardiac output | Imaging of cardiac structures via echocardiography, comparing cardiac output [L/min] to baseline. | at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in Tricuspid Regurgitation (TR) grade (accord. to TR 5-Tier Grading System by the Tricuspid Valve Academic Research Consortium (TVARC)) | Imaging of cardiac structures via echocardiography, comparing TR grade (accord. to TR 5-Tier Grading System TVARC) to baseline. TR grade (accord. to TR 5-Tier Grading System TVARC):
| at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation |
| Exploratory performance endpoint: Changes in pulmonary artery pressure (PAP) | Imaging of cardiac structures via right heart catheterization, comparing PAP [mmHg] to baseline. | 6 months post-implantation |
| Exploratory performance endpoint: Changes in right ventricular pressure (RVP) | Imaging of cardiac structures via right heart catheterization, comparing RVP [mmHg] to baseline. | 6 months post-implantation |
| Exploratory performance endpoint: Changes in right atrial pressure (RAP) | Imaging of cardiac structures via right heart catheterization, comparing RAP [mmHg] to baseline. | 6 months post-implantation |
| Exploratory performance endpoint: Changes in central venous pressure (CVP) | Imaging of cardiac structures via right heart catheterization, comparing CVP [mmHg] to baseline. | 6 months post-implantation |
| Exploratory endpoint: Changes in white blood cell count | Changes in white blood cell count [Gpt/L], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in red blood cell count | Changes in red blood cell count [Tpt/L], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in Hemoglobin | Changes in Hemoglobin [g/dL], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in Hematocrit | Changes in Hematocrit [percentage], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in C-reactive protein | Changes in C-reactive protein [mg/L], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in Lactate Dehydrogenase (LDH) | Changes in LDH [U/L], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in Serum creatinine | Changes in Serum creatinine [µmol/l], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in Estimated Glomerular Filtration Rate (eGFR) | Changes in eGFR [mL/min], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in Blood urea nitrogen | Changes in Blood urea nitrogen [mg/dL], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in Aspartate aminotransferase (ASAT) | Changes in ASAT [U/L] , comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in Alanine aminotransferase (ALT) | Changes in ALT [U/L], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in Albumin | Changes in Albumin [g/L], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in Gamma-glutamyl transferase (γ-GT/GGT) | Changes in γ-GT/GGT [U/L], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in Bilirubin | Changes in Bilirubin [µmol/L], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP) | Changes in NT-proBNP [pg/mL] , comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory endpoint: Changes in Troponin | Changes in Troponin [µg/L], comparing baseline to the respective timepoints. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory performance endpoint: Assessment of total procedural time | Assessment of total procedural time [min], defined as time elapsed between first femoral access and access closure. | during procedure |
| Exploratory performance endpoint: Assessment of device time | Assessment of device time [min], defined as time elapsed between introduction of device into femoral vein and complete withdrawal from the vessel. | during procedure |
| Exploratory performance endpoint: Assessment of total fluoroscopy time | Assessment of total fluoroscopy time [min]. | during procedure |
| Exploratory performance endpoint: Assessment of total contrast utilization | Assessment of total contrast utilization [mL]. | during procedure |
| Exploratory performance endpoint: Assessment of the visibility of Delivery System and Bioprothesis | Assessment of the visibility of Delivery System and Bioprothesis under fluoroscopy [Yes/No]. | during procedure |
| Exploratory clinical benefit endpoint: Changes in subject's weight | Changes in subject's weight [kg]. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory clinical benefit endpoint: Changes in intake of cardiac drugs | Any changes in the use of cardiac drugs. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| Exploratory clinical benefit endpoint: Changes in intake of diuretics | Any changes in the use of diuretics. | at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D002318 | Cardiovascular Diseases |
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