European Registry of Transcatheter Repair for Tricuspid Regurgitation

NCT ID: NCT06307262

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-23

Study Completion Date

2030-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Tricuspid Regurgitation Valvular Heart Disease Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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T-TEER

T-TEER using the PACAL or TriClip device

Intervention Type DEVICE

Other Intervention Names

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Transcatheter tricuspid valve edge-to-edge repair

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LMU Klinikum

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Jörg Hausleiter

Deputy chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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LMU Klinikum

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jörg Hausleiter, Prof. Dr.

Role: CONTACT

+49 89 4400 72360

Lukas Stolz, Dr.

Role: CONTACT

Facility Contacts

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Jörg Hausleiter, Prof. Dr.

Role: primary

+49 89 4400 72360

Lukas Stolz, Dr.

Role: backup

Other Identifiers

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EuroTR Registry

Identifier Type: -

Identifier Source: org_study_id

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