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