Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®
NCT ID: NCT05114850
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2022-04-20
2028-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
OTHER
Eligibility Criteria
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Inclusion Criteria
* Patient/patient's authorized legal guardian gives his consent to participate in the study and signed the corresponding inform consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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P+F Products + Features GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Ignacio J Amat Santos, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Universitario de Valladolid
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Julia Mascherbauer, Dr
Role: primary
Martin Andreas, Dr
Role: primary
Christian Hengstenberg, UnivProf Dr
Role: primary
Liesbeth Rosseel, Dr
Role: primary
Tilmann Schwab, MD
Role: primary
Martin Czerney, MD
Role: primary
Jochen Wöhrle, MD
Role: primary
Marcus Hennersdorf, MD
Role: primary
Bernhard Unsöld, MD
Role: primary
Phillip Nikolai, MD
Role: primary
A. Jeron, MD
Role: primary
Rimantas Benetis, Dr
Role: primary
Jose R Rumoroso, Dr
Role: primary
Jose M Hernandez, Dr
Role: primary
Beatriz Vaquerizo Montilla, Dr
Role: primary
Xavier Freixa Rofastes, Dr
Role: primary
Joan Antoni Gomez, Dr
Role: primary
Xavier Suarez, Dr
Role: primary
Manuel Pan Alvarez, Dr
Role: primary
Raymundo Ocaranza Sánchez, Dr
Role: primary
Maria del Trigo Espinosa, Dr
Role: primary
Luis Nombela Franco, Dr
Role: primary
Raul Moreno, Dr
Role: primary
Ángel Sánchez Recalde, Dr
Role: primary
César Morís, MD
Role: primary
Ignacio Cruz, Dr
Role: primary
Ignacio J Amat Santos, Dr
Role: primary
Andrés Iniguez Romo, Dr
Role: primary
Other Identifiers
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CTS-TRIC-003
Identifier Type: -
Identifier Source: org_study_id
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