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

Phase 2

Terminated

• Conditions: Severe Tricuspid Regurgitation
• Interventions: Device: Edwards Sapien XT Valve

• Registration Number: NCT02387697
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-13
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-16
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Edwards Sapien XT Valve	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.

Primary Outcome Measures

Name	Time	Method
Maximum relative VO2 uptake	at 3 month	we consider the difference of means in maximum relative VO2 uptake at 3 months compared to control group.

Secondary Outcome Measures

Name	Time	Method
ejection fraction (EF)	day 30 and month 3
right ventricular (RV) diameter	day 30 and month 3
right atrial (RA) diameter	day 30 and month 3
hepatic vein diameter	day 30 and month 3
N-terminal pro Brain Natriuretic Peptide (NT-proBNP)	day 30 and month 3
tricuspid regurgitation jet velocity time integral (as assessed by Doppler echocardiography)	day 30 and month 3
aerobic threshold (assessed by spiroergometry)	day 30 and month 3
ventilation efficiency (as assessed by the VE / VCO2 slope in spiroergometry)	day 30 and month 3
Unscheduled rehospitalization	day 30 and month 3
Dyspnoea VAS	day 30 and month 3
Minnesota Living with Heart Failure Questionnaire	day 30 and month 3
NYHA class	day 30 and month 3
6-minutes walk test	day 30 and month 3

Trial Locations

Locations (1)

Charite Universitaetsmedizin, Medizinische Klinik für Kardiologie und Angiologie; 🇩🇪 Berlin, Germany