Skip to content

European Registry of Transcatheter Repair for Tricuspid Regurgitation

European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06307262
Acronym
EuroTR
Enrollment
3000
Registered
2024-03-12
Start date
2023-10-23
Completion date
2030-12-31
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Tricuspid Regurgitation, Valvular Heart Disease

Keywords

Tricuspid regurgitation, TEER, edge-to-edge repair

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.

Interventions

DEVICET-TEER

T-TEER using the PACAL or TriClip device

Sponsors

LMU Klinikum
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
All-cause mortality5 years

Secondary

MeasureTime frameDescription
Procedural Safety5 yearsperiprocedural and in-hospital adverse events
Heart Failure Biomarker5 yearsNT-proBNP level
Dyspnea on exertion5 yearsNew York Heart Association (NYHA) functional class
Functional capacity5 years6-minute walk distance (6MWD)
Right ventricular size5 yearsMid-ventricular diameter of the right ventricle measured by echocardiography
Technical success5 yearsabsence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery
Tricuspid regurgitation reduction5 yearsTricuspid regurgitation severity measured by echocardiography
Tricuspid valve stenosis5 yearsTransvalvular pressure gradient measured by echocardiography
Pulmonary hypertension5 yearsPulmonary artery pressure measured by echocardiography
Right heart congestion5 yearsInferior vena cava dimensions measured by echocardiography
Hospitalization for heart failure5 yearsDate and number of heart failure hospitalizations after the index procedure
Right ventricular function5 yearsRight ventricular fractional area change measured by echocardiography

Countries

Germany

Contacts

Primary ContactJörg Hausleiter, Prof. Dr.
Joerg.Hausleiter@med.uni-muenchen.de+49 89 4400 72360
Backup ContactLukas Stolz, Dr.
Lukas.Stolz@med.uni-muenchen.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026