Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06307262

European Registry of Transcatheter Repair for Tricuspid Regurgitation

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Failure Heart Valve Diseases Tricuspid Valve Insufficiency Valvular Heart Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-TEER

Device

T-TEER using the PACAL or TriClip device

Other names: Transcatheter tricuspid valve edge-to-edge repair

Primary outcomes

  1. All-cause mortality

    Time frame: 5 years

Secondary outcomes

  1. Technical success

    Time frame: 5 years

    absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery

  2. Procedural Safety

    Time frame: 5 years

    periprocedural and in-hospital adverse events

  3. Heart Failure Biomarker

    Time frame: 5 years

    NT-proBNP level

  4. Dyspnea on exertion

    Time frame: 5 years

    New York Heart Association (NYHA) functional class

  5. Functional capacity

    Time frame: 5 years

    6-minute walk distance (6MWD)

  6. Right ventricular size

    Time frame: 5 years

    Mid-ventricular diameter of the right ventricle measured by echocardiography

  7. Right ventricular function

    Time frame: 5 years

    Right ventricular fractional area change measured by echocardiography

  8. Tricuspid regurgitation reduction

    Time frame: 5 years

    Tricuspid regurgitation severity measured by echocardiography

  9. Tricuspid valve stenosis

    Time frame: 5 years

    Transvalvular pressure gradient measured by echocardiography

  10. Pulmonary hypertension

    Time frame: 5 years

    Pulmonary artery pressure measured by echocardiography

  11. Right heart congestion

    Time frame: 5 years

    Inferior vena cava dimensions measured by echocardiography

  12. Hospitalization for heart failure

    Time frame: 5 years

    Date and number of heart failure hospitalizations after the index procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Jörg Hausleiter, Prof. Dr.

CONTACT

[email protected]

+49 89 4400 72360

Lukas Stolz, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Registry information

Official study title

European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR)

Acronym: EuroTR

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Mar 12, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.