Clinical trial NCT02387697: Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL)
Official title: Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Severe Tricuspid Regurgitation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2015-03-13
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Maximum relative VO2 uptake
timeFrame: at 3 month
Secondary outcomes:
measure: NYHA class
timeFrame: day 30 and month 3
measure: ejection fraction (EF)
timeFrame: day 30 and month 3
measure: right ventricular (RV) diameter
timeFrame: day 30 and month 3
measure: right atrial (RA) diameter
timeFrame: day 30 and month 3
measure: hepatic vein diameter
timeFrame: day 30 and month 3
measure: N-terminal pro Brain Natriuretic Peptide (NT-proBNP)
timeFrame: day 30 and month 3
measure: tricuspid regurgitation jet velocity time integral (as assessed by Doppler echocardiography)
timeFrame: day 30 and month 3
measure: aerobic threshold (assessed by spiroergometry)
timeFrame: day 30 and month 3
measure: ventilation efficiency (as assessed by the VE / VCO2 slope in spiroergometry)
timeFrame: day 30 and month 3
measure: Unscheduled rehospitalization
timeFrame: day 30 and month 3
measure: Dyspnoea VAS
timeFrame: day 30 and month 3
measure: Minnesota Living with Heart Failure Questionnaire
timeFrame: day 30 and month 3
measure: 6-minutes walk test
timeFrame: day 30 and month 3
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin, Medizinische Klinik für Kardiologie und Angiologie
Study officials:
References: