Tricuspid Intervention in Heart Failure (TRICI-HF-DZHK24)

Parameters

Inclusion criteria

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

Exclusion criteria

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