Tricuspid RegurgitationTRUSTNCT07133386
TRicuspid Uk STudy
A study testing transcatheter edge to edge repair in people with Tricuspid Regurgitation, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
This is a multicentre, randomised, placebo-controlled trial conducted at St Bartholomew's Hospital, John Radcliff Hospital, Royal Brompton Hospital, and Kings College London Hospital. 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 edge to edge repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2026to Dec 2028
- 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
- Patients aged >18 years at recruitment
- Severe or more symptomatic TR determined by transthoracic echocardiography
- Optimized medical and/or device therapy for a minimum of 30 days
- Medications, including diuretics should be stable over the past 30 days
- Baseline KCCQ 75 or less on minimum 2 assessments at least 2 weeks apart
- New York Heart Association (NYHA) Functional Class II or ambulatory class IV
- Morphology of tricuspid valve suitable for TEER with expectation of a reduction of severity of TR to moderate or less
- Willing to provide written informed consent
Who cannot join
- Presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results or result in an expected life expectancy of less than 12 months
- Active malignancy associated with a prognosis of <1 year
- Left ventricular ejection fraction (LVEF)<20%
- Tricuspid valve leaflet anatomy which may preclude TriClip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:
- Evidence of calcification in the grasping area
- Presence of a severe coaptation defect (>10mm) of the tricuspid leaflets. - Severe leaflet defect(s) preventing proper device placement
Show all 24Show fewer
- Ebstein Anomaly - Identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle.
- Tricuspid valve anatomy not evaluable by transthoracic (TTE) or transoesophageal echo (TOE)
- Rheumatic heart disease affecting the tricuspid valve
- Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction. Note: Patients with concomitant mitral and tricuspid valve disease will have the option of having any significant mitral regurgitation managed, then waiting 60 days prior to being reassessed for the current trial.
- Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the TriClip.
- Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 3.0 cm2 and/or mean gradient ≥3 mmHg as measured by the transthoracic echocardiography
- Pregnant
- Unable to comply with study protocol
- Uncontrolled systemic hypertension with a systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg
- Severe pulmonary hypertension (sPAP>70mmHg) or fixed pre-capillary pulmonary hypertension assessed by cardiac catheterization
- Stroke within prior 90 days
- Chronic dialysis
- Bleeding disorders or hypercoagulable state
- Active peptic ulcer or active gastrointestinal (GI) bleeding
- Ongoing infection requiring current antibiotic therapy (if temporary illness, patients may enrol 30 days after discontinuation of antibiotics with no active infection).
- Known allergy or hypersensitivity to device materials
- Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
- Enrolment in another clinical trial that involves treatment of tricuspid regurgitation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
St Bartholomew's Hospital
London
Kush Patel, +44 0207 3777 000, kush.patel1@nhs.net
Kush Patel
About this study
Official title: TRUST Trial Protocol
This is a multicentre, randomised, placebo-controlled trial conducted at St Bartholomew's Hospital, John Radcliff Hospital, Royal Brompton Hospital, and Kings College London Hospital. The aim is to evaluate the benefits in health status from transcatheter edge to edge repair with the TriClip device in patients with severe or more symptomatic tricuspid regurgitation. A total of 150 patients will be recruited in a 1:1 ratio for TriClip or placebo. The primary endpoint of this study (change in Kansas City Cardiomyopathy Questionnaire between the treatment and placebo arm) will be analysed using a linear mixed model and compared between patients who receive the TriClip versus those who have a placebo procedure.
Study duration: 3 years
- Conditions
- Tricuspid Regurgitation
- Being tested
- transcatheter edge to edge repair, Placebo
- 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 edge to edge repairDevice
Implantation of a tricuspid transcatheter edge to edge device
PlaceboDevice
placebo
| Study group | Role | What they receive |
|---|---|---|
| T-TEER arm | Experimental | Interventional device delivered via the transferral venous route to improve computation of the tricuspid valve leaflets with the aim of reducing tricuspid regurgitation. Receives: Device: transcatheter edge to edge repair |
| Placebo | Placebo comparator | no therapeutic intervention undertaken. Patient will have all the same steps as the TriClip arm without actually having the TriClip device or delivery system inserted into the body. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kansas City Cardiomyopathy Questionnaire
health status questionnaire
Measured: every 2 weeks twice before the intervention and for 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start31 Jul 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, blinded, placebo-controlled randomised clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Oxford University Hospitals NHS Trust, Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133386
- Sponsor's protocol ID
- 338776
- Acronym
- TRUST
- Status last verified
- Feb 2026
- First submitted
- 19 Aug 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRUST Trial Protocol
- ClinicalTrials.gov ID
- NCT07133386
- Acronym / sponsor ID
- TRUST / 338776
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Oxford University Hospitals NHS Trust, Royal Brompton & Harefield NHS Foundation Trust
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Aug 2025 (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.
This is a multicentre, randomised, placebo-controlled trial conducted at St Bartholomew's Hospital, John Radcliff Hospital, Royal Brompton Hospital, and Kings College London Hospital. The aim is to evaluate the benefits in health status from transcatheter edge to edge repair with the TriClip device in patients with severe or more symptomatic tricuspid regurgitation. A total of 150 patients will be recruited in a 1:1 ratio for TriClip or placebo. The primary endpoint of this study (change in Kansas City Cardiomyopathy Questionnaire between the treatment and placebo arm) will be analysed using a linear mixed model and compared between patients who receive the TriClip versus those who have a placebo procedure.
Study duration: 3 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, blinded, placebo-controlled randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| T-TEER arm | Experimental | Device: transcatheter edge to edge repairInterventional device delivered via the transferral venous route to improve computation of the tricuspid valve leaflets with the aim of reducing tricuspid regurgitation. |
| Placebo | Placebo comparator | Device: Placebono therapeutic intervention undertaken. Patient will have all the same steps as the TriClip arm without actually having the TriClip device or delivery system inserted into the body. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged >18 years at recruitment
- Severe or more symptomatic TR determined by transthoracic echocardiography
- Optimized medical and/or device therapy for a minimum of 30 days
- Medications, including diuretics should be stable over the past 30 days
- Baseline KCCQ 75 or less on minimum 2 assessments at least 2 weeks apart
Key exclusion criteria (24 listed)
- Presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results or result in an expected life expectancy of less than 12 months
- Active malignancy associated with a prognosis of <1 year
- Left ventricular ejection fraction (LVEF)<20%
- Tricuspid valve leaflet anatomy which may preclude TriClip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:
- Tricuspid valve anatomy not evaluable by transthoracic (TTE) or transoesophageal echo (TOE)
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 edge to edge repairImplantation of a tricuspid transcatheter edge to edge device | Device | T-TEER arm |
| Placeboplacebo | Device | Placebo |
Primary outcome
Kansas City Cardiomyopathy Questionnaire
Time frame: every 2 weeks twice before the intervention and for 3 months post-intervention
health status questionnaire
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 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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The TRICURE EFS Study
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcatheter edge to edge repair in people with Tricuspid Regurgitation, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 8 inclusion and 24 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: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. Some participants in this study may receive a placebo. 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 Kush Patel (+44 0207 3777 000, kush.patel1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kansas City Cardiomyopathy Questionnaire (time frame: every 2 weeks twice before the intervention and for 3 months post-intervention). 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 27 Feb 2026.