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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 27, 2015
First Posted Date  ICMJE March 13, 2015
Last Update Posted Date September 18, 2018
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2015)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • NYHA class [ Time Frame: day 30 and month 3 ]
  • ejection fraction (EF) [ Time Frame: day 30 and month 3 ]
  • right ventricular (RV) diameter [ Time Frame: day 30 and month 3 ]
  • right atrial (RA) diameter [ Time Frame: day 30 and month 3 ]
  • hepatic vein diameter [ Time Frame: day 30 and month 3 ]
  • N-terminal pro Brain Natriuretic Peptide (NT-proBNP) [ Time Frame: day 30 and month 3 ]
  • tricuspid regurgitation jet velocity time integral (as assessed by Doppler echocardiography) [ Time Frame: day 30 and month 3 ]
  • aerobic threshold (assessed by spiroergometry) [ Time Frame: day 30 and month 3 ]
  • ventilation efficiency (as assessed by the VE / VCO2 slope in spiroergometry) [ Time Frame: day 30 and month 3 ]
  • Unscheduled rehospitalization [ Time Frame: day 30 and month 3 ]
  • Dyspnoea VAS [ Time Frame: day 30 and month 3 ]
  • Minnesota Living with Heart Failure Questionnaire [ Time Frame: day 30 and month 3 ]
  • 6-minutes walk test [ Time Frame: day 30 and month 3 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Severe Tricuspid Regurgitation
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Edwards Sapien XT Valve
  • No Intervention: Group B
    Control group (no surgery) with optimal medical treatment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 16, 2018)		 28
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2015)		 40
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02387697
Other Study ID Numbers  ICMJE TRICAVAL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Prof. Dr. med. Karl Stangl, Charite University, Berlin, Germany
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Charite University, Berlin, Germany
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Edwards Lifesciences
Investigators  ICMJE Not Provided
PRS Account Charite University, Berlin, Germany
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP