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NCT Number: NCT05114850

Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®

Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.

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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Failure Heart Valve Diseases Tricuspid Insufficiency Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum St. Pölten, Sankt Pölten, Lower Austria, Austria

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About this study

The study shall enrol subjects who were treated with the TricValve® Transcatheter Bicaval Valves System® in the Inferior Vena Cava and Superior vena cava. On compliance with the inclusion / exclusion criteria the subject will be enrolled for the observational study.

The study duration for the individual subject will be up to 5 year follow up. The follow-up should be made through pre-established periodic clinical consultations at discharge, 1 month, 6 months, 1 year follow up to 5 years after the procedure. In the consultations, routine exams such as hemogram, renal function, electrocardiogram and echocardiography in order to ascertain the bioprosthesis functioning and its hemodynamic profile are documented as per clinical routine practise.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Successful treatment with TricValve Transcatheter Bicaval Valves System
  • Patient/patient's authorized legal guardian gives his consent to participate in the study and signed the corresponding inform consent

Exclusion criteria

  • no exclusion criterion

Treatment and study plan

Primary outcomes

  1. Number of patients with readmission for HF

    Time frame: up to 12 months

    First unplanned readmission for Heart Failure

Secondary outcomes

  1. All cause mortality

    Time frame: up to 30 days, up to 6 months, up to 5 years

    Number of patients in terms of all cause mortality

  2. Percentage of participants with major adverse events

    Time frame: up to 12 months

    Percentage of participants with major adverse events

  3. Number of participants with severe adverse events

    Time frame: up to 30 days, up to 6 months, up to 5 years

    Number of participants with severe adverse events

  4. Number of patients with readmission for HF

    Time frame: up to 5 years

    First unplanned readmission for Heart Failure

  5. NYHA functional class

    Time frame: up to 30 days, up to 6 months, up to 5 years

    Change of New York Heart Association (NYHA) functional class from III or IV to a lower one

  6. Change in BNP/NTproBNP and diuretic dosage

    Time frame: up to 12 months

    Change in BNP/NTproBNP and diuretic dosage before intervention after intervention

  7. Change of the right atrium size

    Time frame: up to 30 days, up to 6 months, up to 5 years

    Change of the Right Atrium Size assessed by echocardiography

  8. Change of the free valve movement

    Time frame: up to 30 days, up to 6 months, up to 5 years

    Change of the free valve movement assessed by echocardiography

  9. Valve Device Regurgitation

    Time frame: up to 30 days, up to 6 months, up to 5 years

    Number of patients with valve device regurgitation assessed by echocardiography

  10. Number of alive patients

    Time frame: up to 30 days, up to 6 months, up to 5 years

    Number of alive patients free from reintervention related to TricValve System

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Reutterer, Dr

CONTACT

[email protected]

+4369917237200

Sandra Scheidl, MSc

CONTACT

[email protected]

+436601148208

Sponsors and collaborators

Lead sponsor

P+F Products + Features GmbH

Industry

Registry information

Official study title

TRICUS REGISTRY - Retrospective Prospective Multicentric Clinical Follow up of Patients With Severe Tricuspid Regurgitation After Being Treated With the TricValve® Transcatheter Bicaval Valves System.

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Nov 10, 2021
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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