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

January 26, 2023 updated by: P+F Products + Features GmbH

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

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

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Vienna, Austria, 1090
        • Not yet recruiting
        • Medizinische Universität Wien, Department of Cardiac Surgery
        • Contact:
          • Martin Andreas, Dr
      • Vienna, Austria, 1090
        • Not yet recruiting
        • Medizinische Universität Wien, Universitätsklinik für Innere Medizin II
        • Contact:
          • Christian Hengstenberg, UnivProf Dr
    • Niederoesterreich
      • St. Poelten, Niederoesterreich, Austria, 3100
        • Not yet recruiting
        • Universitätsklinikum St. Pölten
        • Contact:
          • Julia Mascherbauer, Dr
      • Aalst, Belgium, 9300
        • Not yet recruiting
        • Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ)
        • Contact:
          • Liesbeth Rosseel, Dr
      • Freiburg, Germany, 79104
        • Not yet recruiting
        • RkK gGmbH im Artemed Klinikverbund Freiburg
        • Contact:
          • Tilmann Schwab, MD
      • Freiburg, Germany, 79189
        • Not yet recruiting
        • Universitatsklinikum Freiburg
        • Contact:
          • Martin Czerney, MD
      • Friedrichshafen, Germany, 88048
        • Not yet recruiting
        • Klinikum Friedrichshafen
        • Contact:
          • Jochen Wöhrle, MD
      • Heilbronn, Germany, 74078
        • Not yet recruiting
        • SLK-Kliniken Heilbronn GmbH
        • Contact:
          • Marcus Hennersdorf, MD
      • Regensburg, Germany, 93053
        • Not yet recruiting
        • Universitätsklinikum Regensburg
        • Contact:
          • Bernhard Unsöld, MD
      • Stuttgart, Germany, 70376
        • Not yet recruiting
        • Robert-Bosch-Krankenhaus
        • Contact:
          • Phillip Nikolai, MD
      • Winnenden, Germany, 71364
        • Not yet recruiting
        • Rems-Murr-Kliniken
        • Contact:
          • A. Jeron, MD
      • Kaunas, Lithuania
        • Not yet recruiting
        • Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos
        • Contact:
          • Rimantas Benetis, Dr
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic Barcelona
        • Contact:
          • Xavier Freixa Rofastes, Dr
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
        • Contact:
          • Xavier Suarez, Dr
      • Barcelona, Spain, 08003
        • Recruiting
        • Parc de Salut Mar
        • Contact:
          • Beatriz Vaquerizo Montilla, Dr
      • Barcelona, Spain, 08907
        • Not yet recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
          • Joan Antoni Gomez, Dr
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofia de Cordoba
        • Contact:
          • Manuel Pan Alvarez, Dr
      • Lugo, Spain, 27003
        • Recruiting
        • Hospital Universitario Lucus Augusti
        • Contact:
          • Raymundo Ocaranza Sánchez, Dr
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Raul Moreno, Dr
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramon Y Cajal
        • Contact:
          • Ángel Sánchez Recalde, Dr
      • Madrid, Spain
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Luis Nombela Franco, Dr
      • Madrid, Spain, 28222
        • Not yet recruiting
        • Hospital Universitario Puerta de Hierro de Majadahonda
        • Contact:
          • Maria del Trigo Espinosa, Dr
      • Oviedo, Spain
        • Recruiting
        • Hospital Universitario Central Asturias
        • Contact:
          • César Morís, MD
      • Salamanca, Spain
        • Recruiting
        • Hospital Clinico Universitario de Salamanca
        • Contact:
          • Ignacio Cruz, Dr
      • Valladolid, Spain
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
        • Contact:
          • Ignacio J Amat Santos, Dr
      • Vigo, Spain
        • Recruiting
        • Hospital Universitario Alvaro Cunqueiro
        • Contact:
          • Andrés Iniguez Romo, Dr
    • Bizkaia
      • Galdakao, Bizkaia, Spain, 48960
        • Not yet recruiting
        • Hospital de Galdakao-Usansolo
        • Contact:
          • Jose R Rumoroso, Dr
    • Malaga
      • Málaga, Malaga, Spain, 29010
        • Not yet recruiting
        • Hospital Virgen de la Victoria
        • Contact:
          • Jose M Hernandez, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with readmission for HF
Time Frame: up to 12 months
First unplanned readmission for Heart Failure
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 30 days, up to 6 months, up to 5 years
Percentage of participants with major adverse events
Time Frame: up to 12 months
Percentage of participants with major adverse events
up to 12 months
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
up to 30 days, up to 6 months, up to 5 years
Number of patients with readmission for HF
Time Frame: up to 5 years
First unplanned readmission for Heart Failure
up to 5 years
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
up to 30 days, up to 6 months, up to 5 years
Change in BNP/NTproBNP and diuretic dosage
Time Frame: up to 12 months
Change in BNP/NTproBNP and diuretic dosage before intervention after intervention
up to 12 months
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
up to 30 days, up to 6 months, up to 5 years
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
up to 30 days, up to 6 months, up to 5 years
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
up to 30 days, up to 6 months, up to 5 years
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
up to 30 days, up to 6 months, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ignacio J Amat Santos, Dr, Hospital Clinico Universitario de Valladolid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2022

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2028

Study Registration Dates

First Submitted

October 29, 2021

First Submitted That Met QC Criteria

October 29, 2021

First Posted (Actual)

November 10, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CTS-TRIC-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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