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

NCT ID: NCT02387697

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-05-31

Brief Summary

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.

Conditions

Severe Tricuspid Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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.

Group Type: EXPERIMENTAL

Edwards Sapien XT Valve

Intervention Type: DEVICE

The device will be implanted in the present study to prevent abdominal venous congestion and to improve the function of the tricuspid valve which is located in the low pressure system in the right heart.

Group B

Control group (no surgery) with optimal medical treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Edwards Sapien XT Valve

The device will be implanted in the present study to prevent abdominal venous congestion and to improve the function of the tricuspid valve which is located in the low pressure system in the right heart.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Karl Stangl

Prof. Dr. med Karl Stangl

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charite Universitaetsmedizin, Medizinische Klinik für Kardiologie und Angiologie

Berlin, , Germany

Countries

Germany

References

Mattig I, Hewing B, Knebel F, Meisel C, Ludwig A, Konietschke F, Stangl V, Stangl K, Laule M, Dreger H. Effect of inferior caval valve implantation on circulating immune cells and inflammatory mediators in severe tricuspid regurgitation. BMC Cardiovasc Disord. 2024 Jul 18;24(1):373. doi: 10.1186/s12872-024-04044-1.

Reference Type: DERIVED

PMID: 39026154 (View on PubMed)

Other Identifiers

TRICAVAL

Identifier Type: -

Identifier Source: org_study_id