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AzTrials

Tricuspid RegurgitationNCT05114850

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

An observational study of Tricuspid Regurgitation and Tricuspid Valve Insufficiency, run by P+F Products + Features GmbH at 28 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
How many people
450 participants
Where
28 sitesin 5 countries
Study dates
20 Apr 2022to Dec 2028
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • no exclusion criterion

Trial locations and contacts

28 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Sandra Scheidl, MSc contact

+436601148208

sscheidl@pfcardiovascular.com

Benjamin Reutterer, Dr contact

+4369917237200

breutterer@pfcardiovascular.com

28 sites in 5 countries

Spain16 sites, 16 recruiting

  • Parc de Salut Mar

    Barcelona, 08003

    Beatriz Vaquerizo Montilla, Dr

    Recruiting

  • Hospital Clinic Barcelona

    Barcelona, 08036

    Xavier Freixa Rofastes, Dr

    Recruiting

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

    Joan Antoni Gomez, Dr

    Not yet recruiting

  • Hospital Universitari Germans Trias i Pujol

    Barcelona

    Xavier Suarez, Dr

    Recruiting

  • Hospital Universitario Reina Sofia de Córdoba

    Córdoba

    Manuel Pan Alvarez, Dr

    Recruiting

  • Hospital de Galdakao-Usansolo

    Galdakao, Bizkaia, 48960

    Jose R Rumoroso, Dr

    Not yet recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

    Raymundo Ocaranza Sánchez, Dr

    Recruiting

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Madrid, 28222

    Maria del Trigo Espinosa, Dr

    Not yet recruiting

  • Hospital Clínico San Carlos

    Madrid

    Luis Nombela Franco, Dr

    Recruiting

  • Hospital Universitario La Paz

    Madrid

    Raul Moreno, Dr

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid

    Ángel Sánchez Recalde, Dr

    Recruiting

  • Hospital Virgen de la Victoria

    Málaga, Malaga, 29010

    Jose M Hernandez, Dr

    Not yet recruiting

  • Hospital Universitario Central Asturias

    Oviedo

    César Morís, MD

    Recruiting

  • Hospital Clínico Universitario de Salamanca

    Salamanca

    Ignacio Cruz, Dr

    Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid

    Ignacio J Amat Santos, Dr

    Recruiting

  • Hospital Universitario Alvaro Cunqueiro

    Vigo

    Andrés Iniguez Romo, Dr

    Recruiting

Other trials in Spain

Germany7 sites, 7 recruiting

  • RkK gGmbH im Artemed Klinikverbund Freiburg

    Freiburg im Breisgau, 79104

    Tilmann Schwab, MD

    Not yet recruiting

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79189

    Martin Czerney, MD

    Not yet recruiting

  • Klinikum Friedrichshafen

    Friedrichshafen, 88048

    Jochen Wöhrle, MD

    Not yet recruiting

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

    Marcus Hennersdorf, MD

    Not yet recruiting

  • Universitätsklinikum Regensburg

    Regensburg, 93053

    Bernhard Unsöld, MD

    Not yet recruiting

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

    Phillip Nikolai, MD

    Not yet recruiting

  • Rems-Murr-Kliniken

    Winnenden, 71364

    A. Jeron, MD

    Not yet recruiting

Other trials in Germany

Austria3 sites, 3 recruiting

  • Universitätsklinikum St. Pölten

    Sankt Pölten, Lower Austria, 3100

    Julia Mascherbauer, Dr

    Not yet recruiting

  • Medizinische Universität Wien, Department of Cardiac Surgery

    Vienna, 1090

    Martin Andreas, Dr

    Not yet recruiting

  • Medizinische Universität Wien, Universitätsklinik für Innere Medizin II

    Vienna, 1090

    Christian Hengstenberg, UnivProf Dr

    Not yet recruiting

Other trials in Austria

Belgium1 site, 1 recruiting

  • Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ)

    Aalst, 9300

    Liesbeth Rosseel, Dr

    Not yet recruiting

Other trials in Belgium

Lithuania1 site, 1 recruiting

  • Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos

    Kaunas

    Rimantas Benetis, Dr

    Not yet recruiting

Other trials in Lithuania

About this study

Official 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.

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

Read the 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.

Keywords
Cardiovascular disease
Medical subject headings
Tricuspid Valve Insufficiency, Heart Failure, Heart Diseases, Heart Valve Diseases, Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with readmission for HF

    First unplanned readmission for Heart Failure

    Measured: up to 12 months

Secondary outcomes (10)

  1. All cause mortality

    Number of patients in terms of all cause mortality

    Measured: up to 30 days, up to 6 months, up to 5 years

  2. Percentage of participants with major adverse events

    Percentage of participants with major adverse events

    Measured: up to 12 months

  3. Number of participants with severe adverse events

    Number of participants with severe adverse events

    Measured: up to 30 days, up to 6 months, up to 5 years

  4. Number of patients with readmission for HF

    First unplanned readmission for Heart Failure

    Measured: up to 5 years

  5. NYHA functional class

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

    Measured: up to 30 days, up to 6 months, up to 5 years

  6. Change in BNP/NTproBNP and diuretic dosage

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

    Measured: up to 12 months

  7. Change of the right atrium size

    Change of the Right Atrium Size assessed by echocardiography

    Measured: up to 30 days, up to 6 months, up to 5 years

  8. Change of the free valve movement

    Change of the free valve movement assessed by echocardiography

    Measured: up to 30 days, up to 6 months, up to 5 years

  9. Valve Device Regurgitation

    Number of patients with valve device regurgitation assessed by echocardiography

    Measured: up to 30 days, up to 6 months, up to 5 years

  10. Number of alive patients

    Number of alive patients free from reintervention related to TricValve System

    Measured: up to 30 days, up to 6 months, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2021
  2. Study start20 Apr 2022
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
450 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05114850
Sponsor's protocol ID
CTS-TRIC-003
Status last verified
Apr 2024
First submitted
29 Oct 2021
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Tricuspid Regurgitation and Tricuspid Valve Insufficiency, run by P+F Products + Features GmbH at 28 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Spain, Germany, Austria, Belgium, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sandra Scheidl, MSc (+436601148208, sscheidl@pfcardiovascular.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with readmission for HF (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05114850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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