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

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

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.

Study Overview

• Status: Terminated
• Conditions: Severe Tricuspid Regurgitation
• Intervention / Treatment: Device: Edwards Sapien XT Valve

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin, Medizinische Klinik für Kardiologie und Angiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Group B; Control group (no surgery) with optimal medical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
NYHA class	day 30 and month 3
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
6-minutes walk test	day 30 and month 3

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: March 12, 2015
• First Posted (Estimate): March 13, 2015

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 16, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Heart Failure; Tricuspid Valve Insufficiency
• Other Study ID Numbers: TRICAVAL