NCT06307262

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Oct 2023Dec 2030

Study Start

First participant enrolled

October 23, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

7.2 years

First QC Date

February 27, 2024

Last Update Submit

March 13, 2024

Conditions

Keywords

Tricuspid regurgitationTEERedge-to-edge repair

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    5 years

Secondary Outcomes (12)

  • Technical success

    5 years

  • Procedural Safety

    5 years

  • Heart Failure Biomarker

    5 years

  • Dyspnea on exertion

    5 years

  • Functional capacity

    5 years

  • +7 more secondary outcomes

Interventions

T-TEERDEVICE

T-TEER using the PACAL or TriClip device

Also known as: Transcatheter tricuspid valve edge-to-edge repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LMU Klinikum

Munich, Bavaria, 81377, Germany

RECRUITING

Related Publications (1)

  • Masiero G, Arturi F, Ceni S, Panza A, Kresoja KP, von Stein J, Fortmeier V, Koell B, Rottbauer W, Kassar M, Goebel B, Denti P, Achouh P, Rassaf T, Barreiro-Perez M, Boekstegers P, Ruck A, Zdanyte M, Adamo M, Vincent F, Schlegel P, Rosch S, Wild MG, Besler C, Toggweiler S, Brunner S, Grapsa J, Patterson T, Thiele H, Kister T, Sticchi A, De Carlo M, Voss F, Polzin A, Popolo Rubbio A, Bedogni F, Stolte T, Nestelberger T, Benito-Gonzalez T, Sanchez-Munoz E, Konstandin MH, Van Belle E, Metra M, Geisler T, Estevez-Loureiro R, Mahabadi AA, Karam N, Maisano F, Lauten P, Praz F, Kessler M, Kalbacher D, Rudolph V, Iliadis C, Lurz P, Hausleiter J, Stolz L, Tarantini G; EuroTR Investigators. Invasive Hemodynamics and Risk Stratification in T-TEER: Moving Beyond ESC Thresholds: EuroTR Registry Insights. Circ Cardiovasc Interv. 2025 Nov 14:e015964. doi: 10.1161/CIRCINTERVENTIONS.125.015964. Online ahead of print.

MeSH Terms

Conditions

Tricuspid Valve InsufficiencyHeart Valve DiseasesHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Lukas Stolz, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy chief

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 12, 2024

Study Start

October 23, 2023

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations