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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)

Primary Purpose

Severe Tricuspid Regurgitation

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Edwards Sapien XT Valve
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Tricuspid Regurgitation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Charite Universitaetsmedizin, Medizinische Klinik für Kardiologie und Angiologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

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.

Control group (no surgery) with optimal medical treatment.

Outcomes

Primary Outcome Measures

Maximum relative VO2 uptake
we consider the difference of means in maximum relative VO2 uptake at 3 months compared to control group.

Secondary Outcome Measures

NYHA class
ejection fraction (EF)
right ventricular (RV) diameter
right atrial (RA) diameter
hepatic vein diameter
N-terminal pro Brain Natriuretic Peptide (NT-proBNP)
tricuspid regurgitation jet velocity time integral (as assessed by Doppler echocardiography)
aerobic threshold (assessed by spiroergometry)
ventilation efficiency (as assessed by the VE / VCO2 slope in spiroergometry)
Unscheduled rehospitalization
Dyspnoea VAS
Minnesota Living with Heart Failure Questionnaire
6-minutes walk test

Full Information

First Posted
February 27, 2015
Last Updated
September 16, 2018
Sponsor
Charite University, Berlin, Germany
Collaborators
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT02387697
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Safety concerns
Study Start Date
January 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Edwards Lifesciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Tricuspid Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Control group (no surgery) with optimal medical treatment.
Intervention Type
Device
Intervention Name(s)
Edwards Sapien XT Valve
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum relative VO2 uptake
Description
we consider the difference of means in maximum relative VO2 uptake at 3 months compared to control group.
Time Frame
at 3 month
Secondary Outcome Measure Information:
Title
NYHA class
Time Frame
day 30 and month 3
Title
ejection fraction (EF)
Time Frame
day 30 and month 3
Title
right ventricular (RV) diameter
Time Frame
day 30 and month 3
Title
right atrial (RA) diameter
Time Frame
day 30 and month 3
Title
hepatic vein diameter
Time Frame
day 30 and month 3
Title
N-terminal pro Brain Natriuretic Peptide (NT-proBNP)
Time Frame
day 30 and month 3
Title
tricuspid regurgitation jet velocity time integral (as assessed by Doppler echocardiography)
Time Frame
day 30 and month 3
Title
aerobic threshold (assessed by spiroergometry)
Time Frame
day 30 and month 3
Title
ventilation efficiency (as assessed by the VE / VCO2 slope in spiroergometry)
Time Frame
day 30 and month 3
Title
Unscheduled rehospitalization
Time Frame
day 30 and month 3
Title
Dyspnoea VAS
Time Frame
day 30 and month 3
Title
Minnesota Living with Heart Failure Questionnaire
Time Frame
day 30 and month 3
Title
6-minutes walk test
Time Frame
day 30 and month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Charite Universitaetsmedizin, Medizinische Klinik für Kardiologie und Angiologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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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