TRICuspid Intervention in Heart Failure Trial

NCT04634266 | Active Not Recruiting DMC

• 2 other identifiers: TRICI-HFTRICI-HF-DZHK24
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 23

Brief Summary

Functional tricuspid regurgitation (TR) is a serious and progressive disease. Guidelines recommend surgical valve repair of severe TR in symptomatic patients. Despite its association with excess mortality and morbidity, TR has been relatively neglected and is severely undertreated. In particular this is because isolated tricuspid surgery remains associated with high mortality rates, and thus, patients with severe TR are often deemed inoperable due to severe co-morbidities and frailty. In recent years, percutaneous CE-mark approved techniques for transcatheter tricuspid valve treatment (TTVT) have emerged as alternatives to surgery. These include (I) transcatheter annuloplasty devices (Tricuspid Cardioband) and (II) transcatheter edge-to-edge repair (TriClip, PASCAL). Several non-randomized studies suggested improved functional outcomes after TTVT, however, to data there is no evidence from randomized controlled trials addressing the actual efficacy of TTVT. The TRICuspid Intervention in Heart Failure trial (TRICI-HF trial) will assess the concept that TTVT will translate into a reduced morbidity and mortality. Patients will be randomly assigned in a 2:1 fashion to TTVT plus OMT (Experimental group) or OMT alone (Control group). TRICI-HF is an industry-independent, investigator-initiated strategy study and investigators may choose any suitable CE-marked percutaneous system "on-label" for TTVT.

Conditions

Heart Failure Attributable to Severe Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality or heart failure hospitalization

  Composite of time to all-cause mortality or heart failure hospitalization - whichever occurs first - at a minimum follow-up of 12 months

  12 months

Secondary Outcomes (11)

• All-cause mortality (unadjusted and adjusted for TR severity at baseline)

  12 months

• Heart failure hospitalizations (frequency and length; unadjusted and adjusted for TR severity at baseline)

  12 months

• Change in Quality of Life as assessed by the MLHFQ from baseline

  12 months

• Re-intervention rates for recurrent tricuspid regurgitation

  12 months

• Change in NYHA Class from baseline (≥III/IV to ≤I/II)

  12 months

Other Outcomes (1)

• Safety of transcatheter tricuspid valve intervention

  1 month

Study Arms (2)

Experimental intervention

EXPERIMENTAL

Transcatheter tricuspid valve treatment (TTVT) plus optimal medical therapy (OMT)

Device: Transcatheter tricuspid valve treatment (TTVT)

Control intervention

NO INTERVENTION

OMT for severe tricuspid regurgitation in right-sided heart failure

Interventions

Transcatheter tricuspid valve treatment (TTVT) DEVICE

Percutaneous CE-mark approved techniques for transcatheter tricuspid valve treatment (TTVT): These include (I) transcatheter annuloplasty devices (Tricuspid Cardioband) and (II) transcatheter edge-to-edge repair (TriClip, PASCAL).

Experimental intervention

Eligibility Criteria

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

You may qualify if:

• Subject is symptomatic due to severe TR despite being on stable OMT for at least 30 days based on judgment of the local heart team. Patients with reduced left ventricular ejection fraction (HFrEF) will likely constitute a minority among eligible patients with isolated severe tricuspid regurgitation (9,13). However, HFrEF patients enrolled into the trial need to be on stable guideline-directed medical therapy for at least 4 weeks..
• Subject is at intermediate or greater estimated risk of mortality with tricuspid valve surgery based on judgment of the local heart team
• New York Heart Association (NYHA) Functional Class II, III or IVa
• Femoral vein access and valve anatomy are determined to be feasible for interventional treatment (including sufficient quality of TTE and TEE imaging)
• Age ≥ 18 years at time of consent
• Subject must provide written informed consent prior to any trial related procedure

You may not qualify if:

• Presence of severe aortic, mitral or pulmonary valve disease OR surgical/interventional treatment at the aortic, mitral or pulmonary valves prior 60 days
• Right heart catheterization (mandatory) with systolic pulmonary artery pressure \> 70 mmHg or substantial pre-capillary pulmonary hypertension (defined as mean pulmonary artery pressure (mPAP) \>30 mmHg plus transpulmonary gradient (TPG) \>17 mmHg or pulmonary vascular resistance (PVR) \>5 wood units)
• Tricuspid valve stenosis (tricuspid mean gradient \> 5 mmHg)
• Pacemaker or ICD leads that would prevent appropriate TTVT
• Prior tricuspid valve procedures or tricuspid valve leaflet anatomy that would interfere with appropriate TTVT (e.g. calcification, Ebstein anomaly, coaptation defect \> 8mm for planned leaflet- and annuloplasty-based therapy)
• Chronic renal failure requiring dialysis
• Tricuspid valve anatomy not evaluable by TTE and TEE
• Myocardial infarction or cerebrovascular accident within prior 90 days
• Life expectancy of less than 12 months

Sponsors & Collaborators

• LMU Klinikum: lead
• Heart and Diabetes Center North Rhine-Westphalia: collaborator
• University Medical Center Mainz: collaborator
• Heart Center Leipzig - University Hospital: collaborator
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator
• University of Leipzig: collaborator

Study Sites (23)

Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Location

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, Germany

Location

Schüchtermann-Klinik

Bad Rothenfelde, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Herzzentrum Uniklinik Köln

Cologne, Germany

Location

St.-Johannes-Hospital Dortmund

Dortmund, Germany

Location

Helios Klinikum Erfurt

Erfurt, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Universitätsklinikum Giessen

Giessen, Germany

Location

Herzzentrum Göttingen

Göttingen, Germany

Location

Herzzentrum UKE

Hamburg, Germany

Location

Katholisches Marienkrankenhaus Hamburg

Hamburg, Germany

Location

MVZ Prof. Mathey/Schofer

Hamburg, Germany

Location

Universitätsklinikum Jena

Jena, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Location

Herzentrum Leipzig

Leipzig, Germany

Location

Universitätsmedizin Mainz

Mainz, Germany

Location

LMU Klinikum

München, Germany

Location

Herzzentrum Siegburg

Siegburg, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Prospective, controlled, multicenter, randomized, open label trial

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 18, 2020
• Study Start: March 25, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

DE (23)