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

Severe Tricuspid Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02387697
• Other study ID #: TRICAVAL
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: January 2015
• Est. completion date: May 2018

Study information

• Verified date: September 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure
• Severe Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	Charite Universitaetsmedizin, Medizinische Klinik für Kardiologie und Angiologie	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Edwards Lifesciences

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum relative VO2 uptake	we consider the difference of means in maximum relative VO2 uptake at 3 months compared to control group.	at 3 month
Secondary	NYHA class		day 30 and month 3
Secondary	ejection fraction (EF)		day 30 and month 3
Secondary	right ventricular (RV) diameter		day 30 and month 3
Secondary	right atrial (RA) diameter		day 30 and month 3
Secondary	hepatic vein diameter		day 30 and month 3
Secondary	N-terminal pro Brain Natriuretic Peptide (NT-proBNP)		day 30 and month 3
Secondary	tricuspid regurgitation jet velocity time integral (as assessed by Doppler echocardiography)		day 30 and month 3
Secondary	aerobic threshold (assessed by spiroergometry)		day 30 and month 3
Secondary	ventilation efficiency (as assessed by the VE / VCO2 slope in spiroergometry)		day 30 and month 3
Secondary	Unscheduled rehospitalization		day 30 and month 3
Secondary	Dyspnoea VAS		day 30 and month 3
Secondary	Minnesota Living with Heart Failure Questionnaire		day 30 and month 3
Secondary	6-minutes walk test		day 30 and month 3