NCT02387697

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

3.3 years

First QC Date

February 27, 2015

Last Update Submit

September 16, 2018

Conditions

Severe Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

NO INTERVENTION

Control group (no surgery) with optimal medical treatment.

Interventions

Edwards Sapien XT ValveDEVICE

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.

Group A

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite Universitaetsmedizin, Medizinische Klinik für Kardiologie und Angiologie

Berlin, 10117, Germany

Location

Related Publications (1)

  • Mattig I, Hewing B, Knebel F, Meisel C, Ludwig A, Konietschke F, Stangl V, Stangl K, Laule M, Dreger H. Effect of inferior caval valve implantation on circulating immune cells and inflammatory mediators in severe tricuspid regurgitation. BMC Cardiovasc Disord. 2024 Jul 18;24(1):373. doi: 10.1186/s12872-024-04044-1.

    PMID: 39026154DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med Karl Stangl

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 13, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations

DE(1)