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

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ClinicalTrials.gov Identifier: NCT02387697
Recruitment Status : Terminated (Safety concerns)
First Posted : March 13, 2015
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Prof. Dr. med. Karl Stangl, Charite University, Berlin, Germany

Study Description
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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.

Condition or disease Intervention/treatment Phase
Severe Tricuspid Regurgitation Device: Edwards Sapien XT Valve Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve
Actual Study Start Date : January 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum relative VO2 uptake [ Time Frame: at 3 month ]
    we consider the difference of means in maximum relative VO2 uptake at 3 months compared to control group.


Secondary Outcome Measures :
  1. NYHA class [ Time Frame: day 30 and month 3 ]
  2. ejection fraction (EF) [ Time Frame: day 30 and month 3 ]
  3. right ventricular (RV) diameter [ Time Frame: day 30 and month 3 ]
  4. right atrial (RA) diameter [ Time Frame: day 30 and month 3 ]
  5. hepatic vein diameter [ Time Frame: day 30 and month 3 ]
  6. N-terminal pro Brain Natriuretic Peptide (NT-proBNP) [ Time Frame: day 30 and month 3 ]
  7. tricuspid regurgitation jet velocity time integral (as assessed by Doppler echocardiography) [ Time Frame: day 30 and month 3 ]
  8. aerobic threshold (assessed by spiroergometry) [ Time Frame: day 30 and month 3 ]
  9. ventilation efficiency (as assessed by the VE / VCO2 slope in spiroergometry) [ Time Frame: day 30 and month 3 ]
  10. Unscheduled rehospitalization [ Time Frame: day 30 and month 3 ]
  11. Dyspnoea VAS [ Time Frame: day 30 and month 3 ]
  12. Minnesota Living with Heart Failure Questionnaire [ Time Frame: day 30 and month 3 ]
  13. 6-minutes walk test [ Time Frame: day 30 and month 3 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387697


Locations
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Germany
Charite Universitaetsmedizin, Medizinische Klinik für Kardiologie und Angiologie
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Edwards Lifesciences
More Information
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Responsible Party: Prof. Dr. med. Karl Stangl, Prof. Dr. med Karl Stangl, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02387697    
Other Study ID Numbers: TRICAVAL
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Heart Failure
Tricuspid Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases