Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or GreaterFIM-TRICSTERNCT07536724
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
A study testing TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR) in people with Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater, run by Medira GmbH at 2 sites in Uzbekistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
- What is being tested?
- TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUzbekistan
- Study dates
- 29 Sep 2026to Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Uzbekistan2 sites, 2 recruiting
- Not yet recruiting
Ministry of Healthcare of the Republic of Uzbekistan "Republican Research Centre of Emergency Medicine"
Tashkent
Dr. Farrukh Djalalov, MD
- Recruiting
Republican Specialized Cardiology Scientific and Practical Medical Center of Cardiology
Tashkent
Prof. Khurshid Fozilov, MD, PhD
About this study
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
- Being tested
- TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR)
- Keywords
- Tricuspid regurgitation, Tricuspid valve, Transcatheter Valve System, Heart valve, Heart diseases, Valve replacement, Bioprothesis, Catheter-based system
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
- Successful access, tracking and withdrawal of the TRICENTO G2 Delivery System [Yes/No]
- Successful deployment and correct positioning of the TRICENTO G2 Bioprosthesis [Yes/No]
Measured: 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.
Measured: 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.
Measured: 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
Measured: during and immediately after the procedure, at discharge (latest 7 days post-implantation), 30 days post-implantation
Secondary outcomes (14)
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
Measured: 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.
Measured: 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).
Measured: 6 months post-implantation
Clinical performance and functionality: Assessment of stent geometry
Assessment of stent geometry assessed via computed tomography (CT).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months, 6 months and 12 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start29 Sep 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or GreaterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exploratory, interventional, single-arm, open-label, multicentre, prospective
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medira GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LS medcap GmbH, Clinical Accelerator
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536724
- Sponsor's protocol ID
- 25-016
- Acronym
- FIM-TRICSTER
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided