TRICuspid Intervention in Heart Failure Trial (TRICI-HF)

LMU Klinikum

Status

Active, not recruiting

Conditions

Heart Failure Attributable to Severe Tricuspid Regurgitation

Treatments

Device: Transcatheter tricuspid valve treatment (TTVT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04634266

TRICI-HF

TRICI-HF-DZHK24 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

360 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

The following inclusion criteria were defined to assure generalizability of the population to be studied:

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

The following exclusion criteria were selected to define a representative study cohort:

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