AzTrials
AzTrials

Tricuspid RegurgitationTRI-FRNCT04646811

Evaluation of Tricuspid Valve Percutaneous Repair System in the Treatment of Severe Secondary Tricuspid Disorders

A study testing Tricuspid valve and Best medical treatment in people with Tricuspid Regurgitation, run by Rennes University Hospital at 26 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Tricuspid regurgitation (TR) is a long-overdue valvular pathology. Its prevalence is significant and increasing with the aging of the population. It is often a consequence of chronic left cardiac pathologies or atrial fibrillation. 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?
Tricuspid valve and Best medical treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
26 sitesin 2 countries
Study dates
10 Feb 2021to 23 Apr 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pre-Inclusion Criteria:
  • Age ≥ 18 years
  • Symptomatic secondary (at least) severe TR (Carpentier Type IIIB (restrictive) and / or I (tricuspid annulus dilation)) stable for at least 30 days
  • NYHA functional class II to IV without cirrhosis and/or ascites
  • Signs of heart failure in the previous 12-months with or without having been hospitalized
  • Stable optimized medical and/or interventional treatment
Show all 47Show fewer
  • Ineligible for corrective action on the valve by surgical approach after a specialized multidisciplinary consultation ("heart team") including at least a cardio-thoracic surgeon, an interventional cardiologist, an imaging-cardiologist and an Anesthesiologist).
  • Signature of an informed consent
  • Definitive Inclusion Criteria:
  • Central core-laboratory analysis : TR characterized before Implantation by at least one of the following criteria:
  • Regurgitation volume > 45 mL / beat
  • Surface of the regurgitant orifice > 40 mm²
  • Vena contracta> 7mm
  • Gap between leaflets ≤ 10 mm (at the presumed location of the clip)
  • Then after the TR severity grading; the Clinical eligibility Committee will valid the inclusion.
  • Non Inclusion Criteria:
  • Patient treated with Mitraclip or other percutaneous approach on the mitral valve in the past 3-month
  • Any prior tricuspid valve procedure that would interfere with placement of the Triclip device
  • Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:
  • Tricuspid valve anatomy not evaluable by TTE and TEE
  • Active endocarditis
  • Evidence of calcification in the grasping area
  • Evidence of stenosis (mean pressure gradient > 5 mmHg or surface area ≤1cm²
  • Presence of a severe coaptation defect (> 1cm) of the tricuspid leaflets
  • Severe leaflet defect(s) preventing proper device placement
  • Epstein anomaly - identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle
  • Myocardial infarction or coronary bypass surgery in the past 3-month
  • Left ventricular ejection fraction ≤35%
  • Cardiac Resynchronization therapy for less than 3-month and patients having a TR that is clearly related to the right ventricular lead positioning
  • Cardioversion for less than 6 weeks
  • Life expectancy irrespective of the valvular heart disease <1 year (due to co-morbidities)
  • Other scheduled cardiac surgery (including registration in cardiac transplant list)
  • Coronary angioplasty in the preceding month
  • Current infection requiring prescription of antibiotics
  • End-stage renal failure (dialysis patient)
  • Severe hepatic insufficiency (disruption of liver metabolism associated with coagulation disorders (factor V <50%))
  • Stroke in the previous 3-month
  • Uncontrolled pre- capillary pulmonary hypertension (right catheterization required) (systolic pulmonary pressure > 60 mmHg)
  • Tricuspid prosthetic valve
  • Pace maker lead or ICD lead that would prevent appropriate placement of the Triclips
  • Nitinol allergy
  • Contraindication, allergy or hypersensibility to dual anti-platelet and anticoagulant therapy
  • Ongoing infection requiring antibiotic therapy
  • Evidence of intra vascular or intra cardiac thrombus
  • Patient who are included in another research protocol
  • Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)
  • Absence of coverage by a social security scheme

Who cannot join

None listed.

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

France23 sites

  • CHU Amiens

    Amiens

  • CHU Angers

    Angers

  • CHU Bordeaux - Hôpital Cardiologique du Haut-Lévêque

    Bordeaux

  • Centre Chirurgical Marie Lannelongue

    Le Plessis-Robinson

  • CHU Lille

    Lille

  • Hôpital Privé Le Bois

    Lille

  • Hospices Civils de Lyon Groupement Hospitalier EST

    Lyon

  • APHM - Hôpital La Timone

    Marseille

  • Hôpital de Saint-Joseph

    Marseille

  • Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier

    Massy

  • Clinique du Millénaire

    Montpellier

  • CHU Nantes - Hôtel Dieu et Hôpital Nord Laennec

    Nantes

  • Hôpital Bichat

    Paris

  • Hôpital Européen Georges Pompidou

    Paris

  • Institut Mutualiste Montsouris

    Paris

  • CHU Rennes - Hôpital Pontchaillou

    Rennes

  • Centre Cardiologique du Nord

    Saint-Denis

  • CHU La Réunion

    Saint-Denis

  • CHU Saint-Etienne

    Saint-Etienne

  • CHU Toulouse - Hôpital Rangueil

    Toulouse

  • Clinique Pasteur

    Toulouse

  • CHU Tours - Hôpital Trousseau

    Tours

  • Médipôle Lyon-Villeurbanne

    Villeurbanne

Other trials in France

Belgium3 sites

  • Service de Cardiologie AZ Sint-Jan

    Bruges

  • Universitair Ziekenhuis Brussel

    Brussels

  • CHU Liège

    Liège

Other trials in Belgium

About this study

Official title: TRI-FR : Multicentric Randomized Evaluation of Tricuspid Valve Percutaneous Repair System (Clip for the Tricuspid Valve) in the Treatment of Severe Secondary Tricuspid Disorders

Tricuspid regurgitation (TR) is a long-overdue valvular pathology. Its prevalence is significant and increasing with the aging of the population. It is often a consequence of chronic left cardiac pathologies or atrial fibrillation. Surgical treatment is recommended in severe symptomatic TR or when the tricuspid annulus is dilated with TR identified prior to scheduled left heart valve surgery. TR are mainly secondary (complicating left heart disease, pulmonary hypertension, atrial fibrillation and atrial dilatation) and pose a difficult problem related to the prognosis. The risk of death or hospitalization is high under medical treatment. Nevertheless, the surgical results are disappointing with significant morbidity and mortality, which are increased by associated comorbidities that are frequent in these sorts of patients. The benefit-risk assessment of surgery is limited by multiple confounders.

This justifies the evaluation of alternative methods aimed at correcting TR with less interventional risk.

Read more

The Clip for the tricuspid valve has been evaluated in the TRILUMINATE trial (inclusion of 85 patients with moderate-to-severe symptomatic TR with a 6-month follow-up). The Triclip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post-procedure. It justified the European Conformity (CE) mark obtention.

A very similar system for the mitral valve (Mitraclip) was previously tested in the randomized EVEREST II study against conventional surgery. The results of the EVEREST II trial justified the recourse to percutaneous edge-to edge mitral repair in patients with primary mitral regurgitation when the patient is contraindicated to conventional surgery.

The Mitra-FR study made it possible to study the role of Mitraclip for treating patient suffering from a secondary mitral insufficiency. It leads to the implementation of this technique in selected patients.

For secondary TR, several series underscored its prevalence and its clinical consequences. TR treatment justifies the proposal for a randomized study. As a matter of fact, evidence for treating are seriously lacking. Surgical surveys report hospital mortality ~ 8.8%. It, therefore, seems necessary to conduct a study as robust as possible to evaluate the contribution of clip for the tricuspid valve (as an innovative percutaneous technique) compared to conventional pharmacological treatment in patients who are unsuitable for a surgical isolated correction of the TR and who has suitable anatomy for clip for the tricuspid valve. It will be necessary to demonstrate clinical, functional (quality of life), echocardiographic and biological benefit of the percutaneous treatment vs optimized medical treatment alone.

Read the detailed description

The principal objective is to demonstrate, over a period of 12-month after randomization, that, on the Packer composite clinical endpoint (CCS) (combining NYHA class, patient global assessment (PGA) and major cardio-vascular events), the tricuspid valve percutaneous repair strategy with clip for the tricuspid valve is superior to best (optimized) medical treatment (BMT) in symptomatic patients with at least severe secondary TR. The Packer clinical composite score is eventually a three-level ordered categorical endpoint, each randomized patient being classifying as improved, unchanged, or worsen, depending on the clinical response over the follow-up period and at 12 months.

Being tested
Tricuspid valve, Best medical treatment
Keywords
secondary Tricuspid Regurgitation, least severe Tricuspid Regurgitation, symptomatic patients
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.

  • Tricuspid valveProcedure or surgery

    Clip for the tricuspid valve implantation on top of best medical therapy

  • Best medical treatmentOther

    Best medical therapy alone

Study groups in NCT04646811
Study groupRoleWhat they receive
Tricuspid valveExperimentaltricuspid valve percutaneous repair strategy with clip for the tricuspid valve
Receives: Procedure: Tricuspid valve
Best medical treatmentOtherNot described
Receives: Other: Best medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Milton Packer clinical composite score

    Milton Packer clinical composite score classifies each patient into 1 of 3 categories (improved, worsened, unchanged), and is determined aggregating evaluation functional using NYHA class, quality of life score using patient global assessment and number of major cardio-vascular events

    Measured: 12 months

Secondary outcomes (22)

  1. number of participants with all-cause mortality

    Measured: 12 months

  2. number of participants with tricuspid valve surgery

    Measured: 12 months

  3. rate of heart failure hospitalizations

    Measured: 12 months

  4. assessment of quality of life improvement

    Kansas City Cardiomyopathy Questionnaire score (KCCQ) The responses are categorized under 3 subscales (symptom burden, physical limitation and quality of life) with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The total KCCQ score represents the mean of the three subscale scores.

    Measured: 0 and 12 months

  5. quality of life score

    Kansas City Cardiomyopathy Questionnaire (KCCQ) The responses are categorized under 3 subscales (symptom burden, physical limitation and quality of life) with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The total KCCQ score represents the mean of the three subscale scores.

    Measured: 6 and 12 months

  6. quality of life score

    Minnesota Living with Heart Failure (MLHF)

    Measured: 6 and 12 months

  7. quality of life score

    EQ5D-5L The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

    The descriptive system :

    5 dimensions : mobility, self-care, usual activities, pain/discomfort, anxiety/depression.

    5 levels : no problems,slight problems, moderate, problems and extreme. Each level corresponds to 1 digit number. The digits for the 5 dimensions are combined into a 5-digit number.

    The EQ VAS : on a vertical visual analogue scale, 100 'The best health you can imagine' 0 'The worst health you can imagine'.

    Measured: 6 and 12 months

  8. quality of life score

    Patient global assessment (PGA)

    Measured: 6 and 12 months

  9. functional evaluation

    NYHA functional class

    Measured: 6 and 12 months

  10. severity of the Tricuspid Regurgitation (TR)

    TR grade

    Measured: 6 and 12 months

  11. walking distance

    6-minute walk test

    Measured: 6 and 12 months

  12. echocardiography parameters

    right heart function

    Measured: 6 and 12 months

  13. echocardiography parameters

    right heart cavities sizes

    Measured: 6 and 12 months

  14. echocardiography parameters

    degree of tricuspid regurgitation

    Measured: 6 and 12 months

  15. echocardiography parameters

    stenosis

    Measured: 6 and 12 months

  16. biological parameters

    parameters renal : creatinine, clearance, AST

    Measured: 6 and 12 months

  17. biological parameters

    hepatic function

    Measured: 6 and 12 months

  18. biological parameters

    NT-proBNP

    Measured: 6 and 12 months

  19. overall survival

    Measured: 6 and 12 months

  20. number of cardiovascular death

    Measured: 6 and 12 months

  21. number of major cardiovascular events

    Measured: 6 and 12 months

  22. Incremental Cost-Effectiveness Ratio expressed as cost per QALY

    Measured: 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2020
  2. Study start10 Feb 2021
  3. Primary completion23 Apr 2024
  4. Study completion23 Apr 2024

Resources

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
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04646811
Sponsor's protocol ID
35RC18_8851_TRI-FR
Other IDs
2020-A00645-34
Acronym
TRI-FR
Status last verified
Jun 2024
First submitted
10 Nov 2020
Last updated
17 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Coisne A, L'Official G, Dreyfus J, Ternacle J, Leurent G, Le Roux PY, Ganivet A, Sportouch-Dukhan C, Lavie-Badie Y, Guerin P, Rouleau F, Diakov C, Van Der Heyden J, Obadia JF, Nejjari M, Karam N, Bernard A, Neylon A, Pierrard R, Tchetche D, Ghostine S, Istratoaie S, Donal E. Echocardiographic Outcomes After Transcatheter Edge-to-Edge Repair in Patients With Isolated Tricuspid Regurgitation: The Tri.Fr Trial. JACC Cardiovasc Imaging. 2026 Mar;19(3):297-307. doi: 10.1016/j.jcmg.2025.09.010. Epub 2025 Nov 19.

    PubMed 41258847

  • Donal E, Dreyfus J, Leurent G, Coisne A, Leroux PY, Ganivet A, Sportouch C, Lavie-Badie Y, Guerin P, Rouleau F, Diakov C, van der Heyden J, Lafitte S, Obadia JF, Nejjari M, Karam N, Bernard A, Neylon A, Pierrard R, Tchetche D, Ghostine S, Ducrocq G, Si Moussi T, Jeu A, Peltier M, Cosyns B, Le Dolley Y, Habib G, Auffret V, Le Ven F, Picard F, Piriou N, Laperche T, Galli E, Istratoaie S, Jouan J, Bonnet G, de Groote P, Anselmi A, Trochu JN, Oger E; Tri-Fr Investigators. Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial. JAMA. 2025 Jan 14;333(2):124-132. doi: 10.1001/jama.2024.21189.

    PubMed 39602173

  • Donal E, Leurent G, Iung B. Are We Right to Believe in the Value of Transcatheter Treatment of Secondary Tricuspid Regurgitation? J Am Coll Cardiol. 2021 Jan 26;77(3):240-242. doi: 10.1016/j.jacc.2020.11.037. No abstract available.

    PubMed 33478647

Questions about this trial

What is this clinical trial studying?

A study testing Tricuspid valve and Best medical treatment in people with Tricuspid Regurgitation, run by Rennes University Hospital at 26 sites in 2 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 47 inclusion and 0 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 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in France, Belgium. 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?

Milton Packer clinical composite score (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04646811, which also lists 3 linked publications.

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 17 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in