European Registry of Transcatheter Repair for Tricuspid Regurgitation

Recruiting

• Conditions: Valvular Heart Disease; Tricuspid Regurgitation; Heart Failure

• Registration Number: NCT06307262
• Lead Sponsor: LMU Klinikum

Brief Summary

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

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 Timeline

• Study Start: 2023-10-23
• Study First Submitted: 2024-02-27
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

LMU Klinikum; 🇩🇪 Munich, Bavaria, Germany