Tricuspid RegurgitationNCT04289870
Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study
A study testing Trillium™ in people with Tricuspid Regurgitation, run by Innoventric LTD at 9 sites in 4 countries.
Trial summary
A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System. Twenty (20) patients in 8 investigational sites will be enrolled. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Trillium™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 24 Jun 2020to 14 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled patients must meet ALL the following criteria:
- Age >40 (no upper limit)
- Patient has clinically significant TR graded as severe based on the presence of systolic hepatic vein flow reversal, and VCW≥7mm or EROA≥40mm^2
- Symptomatic despite medical therapy; patient must be on diuretic therapy.
- Peak central venous pressure of ≥ 15mmHg
- The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid intervention
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- Patient is willing and able to comply with all specified study evaluations.
- Patient has NYHA functional classification of III or IV
- Patient is not eligible for standard-of-care surgical or interventional therapy assessed by the central heart team or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic
- Patient understands the nature of the study and study requirements and is willing to provide written Informed Consent prior to any study-specific procedures.
Who cannot join
- Patients will be excluded from participation if ANY of the following criteria apply:
- Echocardiographic parameters (Any of the following):
- LVEF < 20% II. Evidence of severe right ventricular dysfunction (e.g. right ventricular TAPSE < 13.0mm) III. IVC or SVC anatomy that precludes proper device deployment and function
- Systolic Pulmonary Artery Pressure > 70mmHg
- Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
- Active endocarditis within 90 days of the scheduled implant
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- Significant pericardial effusion
- Intra-cardiac masses, thrombi, or vegetation
- Thrombosis of the venous system
- Space-consuming lesion in the heart or on the valves, thrombus, or microbial colonization of the valves
- Untreated clinically significant coronary artery disease requiring immediate revascularization
- MI or known unstable angina within 30 days prior to the index procedure
- Any therapeutic invasive cardiac procedure within 30 days prior to the index procedure
- Any prior cardiac surgery, within 3 months of the index procedure
- Hemodynamic instability or treated with IV inotropes within 30 days of the index procedure
- Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mm Hg)
- Severe uncontrolled hypotension (SBP≤80 mmHg and/or DBP≤40 mmHg)
- Cerebrovascular Accident (CVA) within the past 90 days
- Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m^2 or patient is on chronic dialysis
- Significant frailty (i.e. Clinical Frailty Scale© (CFS) ≥ 7) within 90 days of the scheduled implant procedure
- Chronic liver disease with a MELD score of 20 or greater
- Chronic anemia (Hb < 9 g/L) not corrected by transfusion
- Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3)
- Bleeding disorders or hypercoagulable state
- Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant
- Contraindication to anticoagulants or antiplatelet agents
- Currently or history of IV drug use
- Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
- Inability to access the femoral vein with a 24 FR guide (e.g., DVT, occluded femoral veins).
- Known allergy to stainless steel, nickel, titanium, PET or contrast agents that cannot be adequately pre-medicated.
- Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
- Impaired judgment
- Undergoing emergent or urgent treatment for tricuspid insufficiency
- Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
- Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months
- Cardiac cachexia
- In the judgment of the Investigator, co-morbid condition(s) that could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
- Patient is under guardianship
- Presence of any prosthetic device in the SVC or IVC (excluding pace-maker, ICD and CRT leads)
- Elevated inflammatory markers within 2 weeks of the scheduled procedure (e.g. CRP>1.5mg/dL).
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Germany3 sites
Heart & Diabetes Center NRW
Bad Oeynhausen, 32545
Herzzentrum der Charité (DHZC)
Berlin
Leipzig Heart Center
Leipzig
Spain3 sites
Hospital Clinic de Barcelona
Barcelona
Hospital Universitario de Salamanca
Salamanca
Hospital Alvaro Cunqueiro, Hospital Universitario de Vigo
Vigo
About this study
Official title: Prospective, Single Arm, Multi-center, First-in-human (FIH) Study to Assess the Safety and Performance of the Innoventric Trillium™ Stent Graft for the Treatment of Severe Tricuspid Regurgitation (TR)
A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System.
Twenty (20) patients in 8 investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, after 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, and 3 years following the index procedure.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Trillium™
- Keywords
- Tricuspid Valve, Tricuspid Valve Insufficiency, Tricuspid Regurgitation
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trillium™Device
Trillium™ Stent Graft for Functional Tricuspid Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Innoventric Trillium™ Stent Graft Single Arm | Experimental | Single-arm, open label, multi-center study Receives: Device: Trillium™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint
Rate of device or procedure-related MAEs
and
Freedom from unplanned surgery or re-intervention, due to life-threatening device or procedure failure
Measured: Evaluated immediately after intervention, discharge and 30 days
Technical performance
Successful access, delivery, and retrieval of the Trillium delivery system, the device is anchored both in SVC and IVC.
Measured: Evaluated immediately after intervention
Efficacy Endpoint
TR grade as measured on the device valves (Echocardiography), or by hepatic vein systolic backflow (Echocardiography), or reduction in peak central venous pressure (Invasive hemodynamic measurement).
Measured: Evaluated immediately after intervention
Secondary outcomes (2)
Safety Endpoint
Composite of all device or procedure-related MAEs.
Measured: Assessment at 3-month, 6-month and 1-year
Efficacy Endpoint
One or more of the following-
- TR grade measured on the device valves (Echocardiography), or by hepatic vein systolic backflow (Echocardiography), or measured by a regurgitant fraction (CMR) [at 30 days, 3-month, 6-month, and 1-year]
- Rate of hospitalizations for HF [at 30 days, 3-month, 6-month, and 1-year]
Or one or more of the following-
- Clinical Frailty Scale (CFS) [at 30 days, 3-month, 6-month, and 1-year]
- HF functional class (NYHA) [at 30 days, 3-month, 6-month, and 1-year]
- Six-minute walk test (6MWT) [at 30 days, 3-month, 6-month, and 1-year]
- The Kansas City Cardiomyopathy Questionnaire (KCCQ) [at 30 days, 3-month, 6-month, and 1-year]
Measured: Assessment at 30 days, 3-month, 6-month and 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start24 Jun 2020
- Primary completion21 Jul 2023
- Study completion14 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies 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
- First In Human study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innoventric LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289870
- Sponsor's protocol ID
- CLD-001
- Status last verified
- Nov 2026
- First submitted
- 5 Feb 2020
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm, Multi-center, First-in-human (FIH) Study to Assess the Safety and Performance of the Innoventric Trillium™ Stent Graft for the Treatment of Severe Tricuspid Regurgitation (TR)
- ClinicalTrials.gov ID
- NCT04289870
- Acronym / sponsor ID
- CLD-001
- Conditions
- Tricuspid Regurgitation
- Keywords
- Tricuspid Valve, Tricuspid Valve Insufficiency, Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Innoventric LTDIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 14 Jul 2026 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System.
Twenty (20) patients in 8 investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, after 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, and 3 years following the index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- First In Human study
| Arm | Type | Receives |
|---|---|---|
| Innoventric Trillium™ Stent Graft Single Arm | Experimental | Device: Trillium™Single-arm, open label, multi-center study |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >40 (no upper limit)
- Patient has clinically significant TR graded as severe based on the presence of systolic hepatic vein flow reversal, and VCW≥7mm or EROA≥40mm^2
- Symptomatic despite medical therapy; patient must be on diuretic therapy.
- Peak central venous pressure of ≥ 15mmHg
- The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid intervention
Key exclusion criteria (40 listed)
- Echocardiographic parameters (Any of the following):
- Systolic Pulmonary Artery Pressure > 70mmHg
- Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
- Active endocarditis within 90 days of the scheduled implant
- Significant pericardial effusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trillium™Trillium™ Stent Graft for Functional Tricuspid Valve Replacement | Device | Innoventric Trillium™ Stent Graft Single Arm |
Primary outcome
Safety Endpoint
Time frame: Evaluated immediately after intervention, discharge and 30 days
Rate of device or procedure-related MAEs and Freedom from unplanned surgery or re-intervention, due to life-threatening device or procedure failure
Technical performance
Time frame: Evaluated immediately after intervention
Successful access, delivery, and retrieval of the Trillium delivery system, the device is anchored both in SVC and IVC.
Efficacy Endpoint
Time frame: Evaluated immediately after intervention
TR grade as measured on the device valves (Echocardiography), or by hepatic vein systolic backflow (Echocardiography), or reduction in peak central venous pressure (Invasive hemodynamic measurement).
2 secondary outcomes
Safety Endpoint
Time frame: Assessment at 3-month, 6-month and 1-year
Efficacy Endpoint
Time frame: Assessment at 30 days, 3-month, 6-month and 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trillium™ in people with Tricuspid Regurgitation, run by Innoventric LTD at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Spain, Belgium, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint (time frame: Evaluated immediately after intervention, discharge and 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.