European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR)

European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR)

To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Valvular Heart Disease; Tricuspid Regurgitation
• Intervention / Treatment: Device: T-TEER

Detailed Description

Background and Rationale:

Tricuspid regurgitation (TR) is a major health and economic burden due to high rates of heart failure hospitalizations, morbidity and mortality. Surcial treatment of TR is associated with high procedural and in-hospital mortality. Due to prohibitive surgical risk, a significant proportion of patients historically remained untreted beyond medical therapy. Transcatheter tricuspid valve (TV) repair and replacement techniques (TTVT) now offer a new treatment perspective for these patients. The EuroTR registry aims at optimizing patient selection prior to TTVT and thus treatment quality by collecting respective data in a real-world setting.

Objectives:

To investigate clinical and survival outcome following transcatheter tricuspid valve repair or replacement.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Jörg Hausleiter, Prof. Dr.; Phone Number: +49 89 4400 72360; Email: Joerg.Hausleiter@med.uni-muenchen.de
• Study Contact Backup: Name: Lukas Stolz, Dr.; Email: Lukas.Stolz@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Recruiting
      • LMU Klinikum
      • Contact: Jörg Hausleiter, Prof. Dr.; Phone Number: +49 89 4400 72360; Email: Joerg.Hausleiter@med.uni-muenchen.de
      • Contact: Lukas Stolz, Dr.; Email: Lukas.Stolz@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with one of the following transcatheter devices for TV repair or replacement (e.g. PASCAL, TriClip, TricValve, Evoque, LuX-Valve)

Description

Inclusion Criteria:

• Patients treated with one of the following transcatheter devices for TV repair or replacement: PASCAL, TriClip, TricValve, Evoque, LuX-Valve
• Age ≥ 18 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery	5 years
Procedural Safety	periprocedural and in-hospital adverse events	5 years
Heart Failure Biomarker	NT-proBNP level	5 years
Dyspnea on exertion	New York Heart Association (NYHA) functional class	5 years
Functional capacity	6-minute walk distance (6MWD)	5 years
Right ventricular size	Mid-ventricular diameter of the right ventricle measured by echocardiography	5 years
Right ventricular function	Right ventricular fractional area change measured by echocardiography	5 years
Tricuspid regurgitation reduction	Tricuspid regurgitation severity measured by echocardiography	5 years
Tricuspid valve stenosis	Transvalvular pressure gradient measured by echocardiography	5 years
Pulmonary hypertension	Pulmonary artery pressure measured by echocardiography	5 years
Right heart congestion	Inferior vena cava dimensions measured by echocardiography	5 years
Hospitalization for heart failure	Date and number of heart failure hospitalizations after the index procedure	5 years

Collaborators and Investigators

• Sponsor: LMU Klinikum

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Tricuspid regurgitation; edge-to-edge repair; TEER
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: EuroTR Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No