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

NCT04646811 | Completed

• 2 other identifiers: 35RC18_8851_TRI-FR2020-A00645-34
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 26

Brief 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. 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. 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.

Conditions

Tricuspid Regurgitation

Keywords

secondary Tricuspid Regurgitation; least severe Tricuspid Regurgitation; symptomatic patients

Outcome Measures

Primary Outcomes (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

  12 months

Secondary Outcomes (22)

• number of participants with all-cause mortality

  12 months

• number of participants with tricuspid valve surgery

  12 months

• rate of heart failure hospitalizations

  12 months

• assessment of quality of life improvement

  0 and 12 months

• quality of life score

  6 and 12 months

Study Arms (2)

Tricuspid valve

EXPERIMENTAL

tricuspid valve percutaneous repair strategy with clip for the tricuspid valve

Procedure: Tricuspid valve

Best medical treatment

OTHER

Other: Best medical treatment

Interventions

Tricuspid valve PROCEDURE

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

Tricuspid valve

Best medical treatment OTHER

Best medical therapy alone

Best medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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)
• 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:

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (26)

Service de Cardiologie AZ Sint-Jan

Bruges, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

CHU Liège

Liège, Belgium

Location

CHU Amiens

Amiens, France

Location

CHU Angers

Angers, France

Location

CHU Bordeaux - Hôpital Cardiologique du Haut-Lévêque

Bordeaux, France

Location

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, France

Location

CHU Lille

Lille, France

Location

Hôpital Privé Le Bois

Lille, France

Location

Hospices Civils de Lyon Groupement Hospitalier EST

Lyon, France

Location

APHM - Hôpital La Timone

Marseille, France

Location

Hôpital de Saint-Joseph

Marseille, France

Location

Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier

Massy, France

Location

Clinique du Millénaire

Montpellier, France

Location

CHU Nantes - Hôtel Dieu et Hôpital Nord Laennec

Nantes, France

Location

Hôpital Bichat

Paris, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

CHU Rennes - Hôpital Pontchaillou

Rennes, France

Location

Centre Cardiologique du Nord

Saint-Denis, France

Location

CHU La Réunion

Saint-Denis, France

Location

CHU Saint-Etienne

Saint-Etienne, France

Location

CHU Toulouse - Hôpital Rangueil

Toulouse, France

Location

Clinique Pasteur

Toulouse, France

Location

CHU Tours - Hôpital Trousseau

Tours, France

Location

Médipôle Lyon-Villeurbanne

Villeurbanne, France

Location

Related Publications (3)

• 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. 2025 Nov 18:S1936-878X(25)00531-5. doi: 10.1016/j.jcmg.2025.09.010. Online ahead of print.

  PMID: 41258847 DERIVED

• 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.

  PMID: 39602173 DERIVED

• 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.

  PMID: 33478647 DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Donal Erwan

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 30, 2020
• Study Start: February 10, 2021
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (23); BE (3)