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

Heart Failure Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05114850
• Other study ID #: CTS-TRIC-003
• Status: Recruiting
• Start date: April 20, 2022
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: P+F Products + Features GmbH
• Contact: Sandra Scheidl, MSc
• Phone: +436601148208
• Email: sscheidl[@]pfcardiovascular.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Austria	Universitätsklinikum St. Pölten	St. Poelten	Niederoesterreich
Austria	Medizinische Universität Wien, Department of Cardiac Surgery	Vienna
Austria	Medizinische Universität Wien, Universitätsklinik für Innere Medizin II	Vienna
Belgium	Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ)	Aalst
Germany	RkK gGmbH im Artemed Klinikverbund Freiburg	Freiburg
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Klinikum Friedrichshafen	Friedrichshafen
Germany	SLK-Kliniken Heilbronn GmbH	Heilbronn
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Robert-Bosch-Krankenhaus	Stuttgart
Germany	Rems-Murr-Kliniken	Winnenden
Lithuania	Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos	Kaunas
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital Universitari Germans Trias i Pujol	Barcelona
Spain	Parc de Salut Mar	Barcelona
Spain	Hospital Universitario Reina Sofia de Córdoba	Córdoba
Spain	Hospital de Galdakao-Usansolo	Galdakao	Bizkaia
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro de Majadahonda	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Virgen de la Victoria	Málaga	Malaga
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

Sponsors (1)

Lead Sponsor	Collaborator
P+F Products + Features GmbH

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Lithuania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with readmission for HF	First unplanned readmission for Heart Failure	up to 12 months
Secondary	All cause mortality	Number of patients in terms of all cause mortality	up to 30 days, up to 6 months, up to 5 years
Secondary	Percentage of participants with major adverse events	Percentage of participants with major adverse events	up to 12 months
Secondary	Number of participants with severe adverse events	Number of participants with severe adverse events	up to 30 days, up to 6 months, up to 5 years
Secondary	Number of patients with readmission for HF	First unplanned readmission for Heart Failure	up to 5 years
Secondary	NYHA functional class	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
Secondary	Change in BNP/NTproBNP and diuretic dosage	Change in BNP/NTproBNP and diuretic dosage before intervention after intervention	up to 12 months
Secondary	Change of the right atrium size	Change of the Right Atrium Size assessed by echocardiography	up to 30 days, up to 6 months, up to 5 years
Secondary	Change of the free valve movement	Change of the free valve movement assessed by echocardiography	up to 30 days, up to 6 months, up to 5 years
Secondary	Valve Device Regurgitation	Number of patients with valve device regurgitation assessed by echocardiography	up to 30 days, up to 6 months, up to 5 years
Secondary	Number of alive patients	Number of alive patients free from reintervention related to TricValve System	up to 30 days, up to 6 months, up to 5 years