First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation

N/ANot Yet RecruitingNCT07536724

Medira GmbH10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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 * 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

Outcomes

Primary Outcomes

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 \[given as percentage of participants\] 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 \[Yes/No\]

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: during and immediately after the procedure, at discharge (latest 7 days post-implantation), 30 days post-implantation

Secondary Outcomes

Clinical performance and functionality of the TRICENTO G2 Bioprothesis assessed via echocardiography

Assessment via echocardiography (TEE/TTE): * Fully functional bioprosthetic valve demonstrating unrestricted inflow in diastole and no backflow in systole beyond the closing volume * Exclusion of para-prosthetic leakage * Changes in hepatic vein systolic backflow

Time frame: 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

Change in peak central venous pressure (CVP \[mmHg\]) or CVP pulsatility or differential pressure \[mmHg\] over the prosthetic valve right atrium-central venous system.

Time frame: 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).

Time frame: 6 months post-implantation

Clinical performance and functionality: Assessment of stent geometry

Assessment of stent geometry assessed via computed tomography (CT).

Time frame: 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).

Time frame: 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).

Time frame: 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: * Grade 0 = none (no clinical edema), * Grade 1 = ankle (up to the height of the ankle level), * Grade 2 = shin (extending to the shin) * Grade 3 = thigh (extending to the thigh) * Grade 4 = generalized edema (anasarca)

Time frame: 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: * I No limitations: No limitations of physical activity, ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea * II Slight limitation: Slight limitation of functional activity, comfortable at rest, ordinary physical activity can cause fatigue, palpitation,, and dyspnea * III Moderate limitation: Marked limitation of physical activity, comfortable at rest, less-than-ordinary activity can cause fatigue, palpitation, and dyspnea * IV Severe limitation: Unable to carry out physical activity without discomfort, symptoms at rest

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 3 months, 6 months and 12 months post-implantation

First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts