Tricuspid RegurgitationNCT04905017
Trisol System EFS Study
A study testing Transcatheter Tricuspid Valve Replacement in people with Tricuspid Regurgitation, run by Trisol Medical at 7 sites in United States.
Trial summary
The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Transcatheter Tricuspid Valve Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Mar 2022to 1 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age >18 years.
- Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
- Participant has symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR) as determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).
- New York Heart Association (NYHA) Functional Class II to IVa.
- Participant is deemed at high surgical risk or greater for tricuspid valve surgery and appropriate for transcatheter tricuspid valve replacement as determined by the local Heart Team.
- Participant adequately treated based upon medical standards, including for coronary artery disease, mitral regurgitation, and Guideline-Directed Medical Therapy (GDMT) for heart failure for at least 30-days prior to index procedure.
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- Male or non-pregnant female.
- Participant understands the nature of the procedure and provides written informed consent prior to any study specific assessments.
- Participant is willing and able to comply with the specified study requirements and follow-up evaluations.
- Participant is anatomically suitable for the Trisol system, including trans-jugular access as per imaging requirements, and is approved by the Subject Screening Committee
Who cannot join
- Previous tricuspid valve repair or replacement which may impede proper study device delivery or deployment.
- Stroke or transient ischemic event within the previous 90 days.
- Acute myocardial infarction within the previous 90 days.
- Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within the previous 30 days.
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- New or untreated right heart chamber or/and superior vena cava intracardiac mass, thrombus, or vegetation.
- Systolic pulmonary arterial pressure (sPAP) > 80 mmHg as measured by pulmonary pressure catheter.
- Severe RV dysfunction with RV Stroke Work Index (RVSWI) g/m2/beat <400 and Pulmonary Artery Pulsatile index (PAPi) <2.
- Ongoing sepsis, including active endocarditis.
- Active infection requiring current antibiotic therapy.
- Known bleeding diathesis or hypercoagulable state.
- Blood dyscrasias as defined: leukopenia (WBC <3000 cells/mm3), thrombocytopenia (platelet count <50,000 cells/mm3).
- Active gastrointestinal (GI) bleeding or history of GI bleed within the previous 60 days that would preclude anticoagulation.
- LVEF <25% as measured by resting echocardiogram within 30 days prior to index procedure.
- Patients in whom transesophageal echocardiography is contraindicated.
- Aortic, mitral or pulmonary valve disease (severe stenosis or severe regurgitation) requiring intervention or performed within 90 days prior to enrollment.
- Severe tricuspid valve stenosis.
- Need for any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days prior to index procedure.
- Need for emergent or urgent non cardiac surgery for any reason.
- Contraindication or known allergy to device components, anticoagulation therapy with a vitamin K antagonist, or to contrast media that cannot be adequately premedicated.
- History of cardiac transplantation, or participant currently listed for urgent transplant (e.g., UNOS Status 1).
- Presence of any known life-threatening non-cardiac disease that will limit the subject's life expectancy to less than one year.
- Contraindication or known hypersensitivity to anticoagulant therapy and/or antiplatelet therapy.
- Venous anatomy unsuitable for implant delivery.
- Pacemaker or ICD lead present that would prevent appropriate valve placement.
- Active COVID-19 infection.
- Comorbid condition(s) that, in the opinion of the investigator, 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.
- Previously enrolled in this study or 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
Caryn Bernstein, MN FNP-BC CCRC, 404.605.5688, caryn.bernstein@piedmont.org
Vinod Thourani, MD
- Recruiting
University of Virginia Cardiology
Charlottesville, Virginia, 22908
Linda Bailes Bryceland, RN, 434-982-1058, SL9PC@virginia.edu
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Amar Krishnaswamy, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Rajendra Makkar, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Natalie Jackson, MPH, 615-343-1782, natalie.jackson@vumc.org
Kashish Goel, MD
- Recruiting
Columbia University Medical Center/NYPH
New York, New York, 10032
Kate Dalton, MS, RD, 347-514-3366, keb2114@cumc.columbia.edu
- Not yet recruiting
Main Line Health / Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
Ann Marie Chikowski, MBA, RN, CCRC, 484.476.8579, Chikowskia@MLHS.ORG
William Gray, MD FACC FSCAI
About this study
Official title: Early Feasibility Study of the Trisol System
The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
Read the detailed description
A prospective, single-arm, open-label, multi-center early feasibility clinical study.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Transcatheter Tricuspid Valve Replacement
- 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.
Transcatheter Tricuspid Valve ReplacementDevice
Replacement of the tricusupid valve using Trisol System in a transcatheter approach
| Study group | Role | What they receive |
|---|---|---|
| Treatment with the Trisol System | Experimental | Not described Receives: Device: Transcatheter Tricuspid Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device-related serious adverse events
Rate of device-related serious adverse events, including death (cardiovascular and non- cardiovascular), MI (MVARC definitions), disabling stroke, life-threatening bleeding (MVARC type III-V), renal failure requiring dialysis, emergency surgery, need for additional surgical procedures due to device failure
Measured: Up to 30 days
Rate of technical success
Technical success: delivery and deployment of the device in the correct position and retrieval of the delivery system.
Measured: During procedure
Rate of procedural success
Procedural success: freedom from emergency surgery or reintervention related to the device or access procedure, without death, stroke, or device dysfunction
Measured: Up to 30 days
Change in TR from baseline
Change in TR from baseline: reduction in TR grade immediately following implantation as compared to baseline TR grade, based on TEE imaging.
Measured: During procedure
Secondary outcomes (4)
Clinical performance endpoints - Change in TR from baseline
Change in TR from baseline: reduction in TR grade as compared to baseline TR grade, based on TTE imaging
Measured: At 30 days, 6 months, 12 months
Clinical performance endpoints - Change in NYHA class
New York Heart Association (NYHA) functional class: change in NYHA from baseline
Measured: At 30 days, 6 months, 12 months, and then annually
Clinical performance endpoints --minute walk test
Six-minute walk test: change in distance (m) from baseline
Measured: At 30 days, 6 months and 12 months
Quality-of-Life: change from baseline as measured by Kansas City Cardiomyopathy Questionnaire
Clinical performance endpoints -Quality-of-Life: change from baseline as measured by Kansas City Cardiomyopathy Questionnaire
Measured: At 30 days, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start2 Mar 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jul 2031 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trisol Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isaac George, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905017
- Sponsor's protocol ID
- DMS-10809
- Status last verified
- Jan 2025
- First submitted
- 20 May 2021
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the Trisol System
- ClinicalTrials.gov ID
- NCT04905017
- Acronym / sponsor ID
- DMS-10809
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Trisol MedicalIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 27 May 2021 (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.
The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
Detailed description
A prospective, single-arm, open-label, multi-center early feasibility clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with the Trisol System | Experimental | Device: Transcatheter Tricuspid Valve Replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >18 years.
- Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
- Participant has symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR) as determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).
- New York Heart Association (NYHA) Functional Class II to IVa.
- Participant is deemed at high surgical risk or greater for tricuspid valve surgery and appropriate for transcatheter tricuspid valve replacement as determined by the local Heart Team.
Key exclusion criteria (29 listed)
- Previous tricuspid valve repair or replacement which may impede proper study device delivery or deployment.
- Stroke or transient ischemic event within the previous 90 days.
- Acute myocardial infarction within the previous 90 days.
- Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.
- Untreated clinically significant coronary artery disease requiring revascularization.
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 |
|---|---|---|
| Transcatheter Tricuspid Valve ReplacementReplacement of the tricusupid valve using Trisol System in a transcatheter approach | Device | Treatment with the Trisol System |
Primary outcome
Rate of device-related serious adverse events
Time frame: Up to 30 days
Rate of device-related serious adverse events, including death (cardiovascular and non- cardiovascular), MI (MVARC definitions), disabling stroke, life-threatening bleeding (MVARC type III-V), renal failure requiring dialysis, emergency surgery, need for additional surgical procedures due to device failure
Rate of technical success
Time frame: During procedure
Technical success: delivery and deployment of the device in the correct position and retrieval of the delivery system.
Rate of procedural success
Time frame: Up to 30 days
Procedural success: freedom from emergency surgery or reintervention related to the device or access procedure, without death, stroke, or device dysfunction
Change in TR from baseline
Time frame: During procedure
Change in TR from baseline: reduction in TR grade immediately following implantation as compared to baseline TR grade, based on TEE imaging.
4 secondary outcomes
Clinical performance endpoints - Change in TR from baseline
Time frame: At 30 days, 6 months, 12 months
Clinical performance endpoints - Change in NYHA class
Time frame: At 30 days, 6 months, 12 months, and then annually
Clinical performance endpoints --minute walk test
Time frame: At 30 days, 6 months and 12 months
Quality-of-Life: change from baseline as measured by Kansas City Cardiomyopathy Questionnaire
Time frame: At 30 days, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Tricuspid Regurgitation
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The TRICURE EFS Study
Tricuspid Valve Regurgitation, Heart Valve Diseases
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TRISCEND JAPAN Study
Tricuspid Valve Regurgitation, Heart Valve Diseases
Recruiting
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
Recruiting
The TRICURE US IDE Pivotal Study
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Recruiting
EFS of the DUO System for Tricuspid Regurgitation
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
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.
Isaac George, MD principal investigator
Columbia University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Tricuspid Valve Replacement in people with Tricuspid Regurgitation, run by Trisol Medical at 7 sites in United States.
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 29 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: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ron Davidson, B. Sc., MBA (+972 528998866, rond@trisol-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of device-related serious adverse events (time frame: Up to 30 days). The study lists 4 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 21 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.