Clinical trial NCT05114850: Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tricuspid Regurgitation
Tricuspid Valve Insufficiency
Tricuspid Insufficiency
Heart Failure
Heart Diseases
Heart Valve Diseases
Keywords: Cardiovascular disease
Lead sponsor: P+F Products + Features GmbH
Sponsor class: INDUSTRY
First posted: 2021-11-10
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with readmission for HF
timeFrame: up to 12 months
Secondary outcomes:
measure: All cause mortality
timeFrame: up to 30 days, up to 6 months, up to 5 years
measure: Percentage of participants with major adverse events
timeFrame: up to 12 months
measure: Number of participants with severe adverse events
timeFrame: up to 30 days, up to 6 months, up to 5 years
measure: Number of patients with readmission for HF
timeFrame: up to 5 years
measure: NYHA functional class
timeFrame: up to 30 days, up to 6 months, up to 5 years
measure: Change in BNP/NTproBNP and diuretic dosage
timeFrame: up to 12 months
measure: Change of the right atrium size
timeFrame: up to 30 days, up to 6 months, up to 5 years
measure: Change of the free valve movement
timeFrame: up to 30 days, up to 6 months, up to 5 years
measure: Valve Device Regurgitation
timeFrame: up to 30 days, up to 6 months, up to 5 years
measure: Number of alive patients
timeFrame: up to 30 days, up to 6 months, up to 5 years
Other outcomes:
Locations:
city: St. Poelten
country: Austria
facility: Universitätsklinikum St. Pölten
state: Niederoesterreich
city: Vienna
country: Austria
facility: Medizinische Universität Wien, Department of Cardiac Surgery
city: Vienna
country: Austria
facility: Medizinische Universität Wien, Universitätsklinik für Innere Medizin II
city: Aalst
country: Belgium
facility: Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ)
city: Freiburg
country: Germany
facility: RkK gGmbH im Artemed Klinikverbund Freiburg
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Friedrichshafen
country: Germany
facility: Klinikum Friedrichshafen
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn GmbH
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Winnenden
country: Germany
facility: Rems-Murr-Kliniken
city: Kaunas
country: Lithuania
facility: Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos
city: Galdakao
country: Spain
facility: Hospital de Galdakao-Usansolo
state: Bizkaia
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
state: Malaga
city: Barcelona
country: Spain
facility: Parc de Salut Mar
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia de Córdoba
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro de Majadahonda
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Oviedo
country: Spain
facility: Hospital Universitario Central Asturias
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Vigo
country: Spain
facility: Hospital Universitario Alvaro Cunqueiro
Study officials:
affiliation: Hospital Clínico Universitario de Valladolid
name: Ignacio J Amat Santos, Dr
role: PRINCIPAL_INVESTIGATOR
References: