RecruitingNCT05114850

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

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

Sponsor

P+F Products + Features GmbH

Enrollment

450 participants

Start Date

Apr 20, 2022

Study Type

OBSERVATIONAL

Conditions

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

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an observational follow-up study for patients who have already received the TricValve system — a transcatheter device placed in the two main veins that return blood to the heart (the superior and inferior vena cavae) to treat severe tricuspid valve disease. The tricuspid valve sits on the right side of the heart, and when it leaks badly, it can cause fluid buildup, fatigue, and shortness of breath. The TricValve is a less invasive alternative to open-heart surgery. This registry collects long-term data on how patients do after the procedure. **You may be eligible if...** - You have already been successfully treated with the TricValve Transcatheter Bicaval Valves System - You or your legal guardian are willing to consent to having your data collected **You may NOT be eligible if...** - There are no formal exclusion criteria — all patients who have received TricValve are eligible to participate This is an observational data collection study and does not involve any new or experimental treatments. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(28)

Universitätsklinikum St. Pölten

Sankt Pölten, Lower Austria, Austria

Medizinische Universität Wien, Department of Cardiac Surgery

Vienna, Austria

Medizinische Universität Wien, Universitätsklinik für Innere Medizin II

Vienna, Austria

Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ)

Aalst, Belgium

RkK gGmbH im Artemed Klinikverbund Freiburg

Freiburg im Breisgau, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Klinikum Friedrichshafen

Friedrichshafen, Germany

SLK-Kliniken Heilbronn GmbH

Heilbronn, Germany

Universitätsklinikum Regensburg

Regensburg, Germany

Robert-Bosch-Krankenhaus

Stuttgart, Germany

Rems-Murr-Kliniken

Winnenden, Germany

Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos

Kaunas, Lithuania

Hospital de Galdakao-Usansolo

Galdakao, Bizkaia, Spain

Hospital Virgen de la Victoria

Málaga, Malaga, Spain

Parc de Salut Mar

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Universitari de Bellvitge

Barcelona, Spain

Hospital Universitari Germans Trias i Pujol

Barcelona, Spain

Hospital Universitario Reina Sofia de Córdoba

Córdoba, Spain

Hospital Universitario Lucus Augusti

Lugo, Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Central Asturias

Oviedo, Spain

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Hospital Universitario Alvaro Cunqueiro

Vigo, Spain

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