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

Recruiting

• Conditions: Tricuspid Valve Insufficiency; Heart Diseases; Heart Valve Diseases; Heart Failure; Tricuspid Regurgitation; Tricuspid Insufficiency

• Registration Number: NCT05114850
• Lead Sponsor: P+F Products + Features GmbH

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.

Study Timeline

• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-10
• Study Start: 2022-04-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2025-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with readmission for HF	up to 12 months	First unplanned readmission for Heart Failure

Secondary Outcome Measures

Name	Time	Method
Change in BNP/NTproBNP and diuretic dosage	up to 12 months	Change in BNP/NTproBNP and diuretic dosage before intervention after intervention
All cause mortality	up to 30 days, up to 6 months, up to 5 years	Number of patients in terms of all cause mortality
NYHA functional class	up to 30 days, up to 6 months, up to 5 years	Change of New York Heart Association (NYHA) functional class from III or IV to a lower one
Percentage of participants with major adverse events	up to 12 months	Percentage of participants with major adverse events
Number of patients with readmission for HF	up to 5 years	First unplanned readmission for Heart Failure
Number of participants with severe adverse events	up to 30 days, up to 6 months, up to 5 years	Number of participants with severe adverse events
Change of the right atrium size	up to 30 days, up to 6 months, up to 5 years	Change of the Right Atrium Size assessed by echocardiography
Change of the free valve movement	up to 30 days, up to 6 months, up to 5 years	Change of the free valve movement assessed by echocardiography
Valve Device Regurgitation	up to 30 days, up to 6 months, up to 5 years	Number of patients with valve device regurgitation assessed by echocardiography
Number of alive patients	up to 30 days, up to 6 months, up to 5 years	Number of alive patients free from reintervention related to TricValve System

Trial Locations

Locations (28)

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario Central Asturias; 🇪🇸 Oviedo, Spain

Hospital de Galdakao-Usansolo; 🇪🇸 Galdakao, Bizkaia, Spain

Universitätsklinikum St. Pölten; 🇦🇹 St. Poelten, Niederoesterreich, Austria

Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos; 🇱🇹 Kaunas, Lithuania

Medizinische Universität Wien, Department of Cardiac Surgery; 🇦🇹 Vienna, Austria

Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ); 🇧🇪 Aalst, Belgium

RkK gGmbH im Artemed Klinikverbund Freiburg; 🇩🇪 Freiburg, Germany

Medizinische Universität Wien, Universitätsklinik für Innere Medizin II; 🇦🇹 Vienna, Austria

SLK-Kliniken Heilbronn GmbH; 🇩🇪 Heilbronn, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Klinikum Friedrichshafen; 🇩🇪 Friedrichshafen, Germany

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany

Universitätsklinikum Regensburg; 🇩🇪 Regensburg, Germany

Rems-Murr-Kliniken; 🇩🇪 Winnenden, Germany

Hospital Virgen de la Victoria; 🇪🇸 Málaga, Malaga, Spain

Parc de Salut Mar; 🇪🇸 Barcelona, Spain

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Barcelona, Spain

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Universitario Reina Sofia de Córdoba; 🇪🇸 Córdoba, Spain

Hospital Universitario Lucus Augusti; 🇪🇸 Lugo, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Universitario Alvaro Cunqueiro; 🇪🇸 Vigo, Spain

Hospital Universitario Puerta de Hierro de Majadahonda; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain