Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL)

Charité University Medicine Berlin

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Severe Tricuspid Regurgitation

Treatments: Device: Edwards Sapien XT Valve

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02387697

TRICAVAL

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of implanting an Edwards Sapien XT Valve into the vena cava inferior (VCI; between right atrium and the hepatic vein) on clinical variables, exercise tolerance and well being in patients with severe tricuspid regurgitation and signs of right heart failure.

Enrollment: 28 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe symptomatic tricuspid regurgitation with a significant regurgitation jet into the caval and hepatic veins
• Optimal medical treatment
• High surgical risk with STS Score ≥ 10 or logistic EuroSCORE I ≥ 15 or any contraindication for conventional valve replacement/repair
• NYHA class of at least II
• Written informed consent

Exclusion criteria

• VCI diameter > 32 mm
• Severe left ventricular dysfunction with LVEF < 30%
• Severe mitral insufficiency
• Estimated life expectancy < 12months (360 days) due to carcinoma, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease
• Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
• Evidence of stroke / TIA during the last 180 days
• Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cells/mL), or any known blood clotting disorder
• Evidence of an intracardiac mass, thrombus or vegetation
• Active upper GI bleeding within 1 month (30 days) prior to procedure
• Patients with an acute emergency
• Contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure
• Allergy against the use of implanted stent / prosthesis
• Patient undergoing regular dialysis or a serum creatinine above 3.0 mg/dl
• Patients unsuitable for implantation because of thrombosis of the lower venous system or vena cava filter
• Active bacterial endocarditis within 6 months (180 days) of procedure.
• Women of childbearing potential without highly effective contraception (PEARL-Index < 1%)
• Inability to comply with all of the study procedures and follow-up visits
• Subjects who are legally detained in an official institute (according to § 20 MPG)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Group A

Experimental group

Description:

Transfemoral implantation of an Edwards Sapien XT Valve into the vena cava inferior (VCI). For better stability and for downsizing of the VCI diameter the valve will be implanted after preparation of a landing zone. This includes implantation of one or two self expandable stents into the VCI prior to the final deployment of the valve.

Treatment:

Device: Edwards Sapien XT Valve

Group B

No Intervention group

Description:

Control group (no surgery) with optimal medical treatment.