EVOQUE-BNL

First Experience with EVOQUE Transcatheter Tricuspid Valve Implantation in the Benelux: An observational study Reporting Early Outcomes - EVOQUE-BNL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON58161

Enrollment

Registered

2025-11-24

Start date

2025-12-01

Completion date

Unknown

Last updated

2025-12-01

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

Conditions

Tricuspid regurgitation Leaking right heart valve

Interventions

This study does not involve any investigational product or investigational intervention. The transcatheter valve replacement with the EVOQUE bioprosthesis is part of routine clinical care and was perf

Eligibility

Inclusion criteria

Inclusion criteria: All patients who underwent an attempted or successful transcatheter tricuspid valve replacement (TTVR) with the EVOQUE system at a center in the BENELUXAge = 18 years at the time of the procedureSufficient clinical and echocardiographic data available in the medical recoed to assess the study outcomes

Exclusion criteria

Exclusion criteria: Essential procedural, clinical, or echocardiographic information is missing, making assessment of the primary and secondary outcome measures impossible.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is clinical success at 30 days according to the TVARC criteria, defined as meeting all of the following criteria:Survival without urgent re-interventionAdequate valve function: residual TR = mild (=1+) and a mean transvalvular tricuspid gradient <5 mmHg, with no more than mild paravalvular leakNo major TVARC safety events within 30 days:Cardiovascular mortalityNon-fatal stroke or TIALife-threatening or disabling bleedingAcute kidney injury (KDIGO stage 2–3)Myocardial infarctionDevice embolization or malposition with hemodynamic consequencesAcute valve thrombosis or obstructive dysfunctionMajor vascular complications (TVARC definition)	—

Measure

Time frame

The primary endpoint is clinical success at 30 days according to the TVARC criteria, defined as meeting all of the following criteria:Survival without urgent re-interventionAdequate valve function: residual TR = mild (=1+) and a mean transvalvular tricuspid gradient <5 mmHg, with no more than mild paravalvular leakNo major TVARC safety events within 30 days:Cardiovascular mortalityNon-fatal stroke or TIALife-threatening or disabling bleedingAcute kidney injury (KDIGO stage 2–3)Myocardial infarctionDevice embolization or malposition with hemodynamic consequencesAcute valve thrombosis or obstructive dysfunctionMajor vascular complications (TVARC definition)

—

Secondary

Measure	Time frame
Secondary endpoints: TR grade at 12 months.All-cause mortality at 30 days and 12 months.Composite clinical endpoint (e.g., all-cause mortality + HF readmissions) at 12 months.Change in NYHA class, 6MWT, and KCCQ between baseline and 30 days/12 months.Change in echocardiographic and hemodynamic parameters (RV function, RA/RV dimensions, sPAP).Incidence of TVARC-defined complications (periprocedural and during follow-up).	—

Measure

Time frame

Secondary endpoints: TR grade at 12 months.All-cause mortality at 30 days and 12 months.Composite clinical endpoint (e.g., all-cause mortality + HF readmissions) at 12 months.Change in NYHA class, 6MWT, and KCCQ between baseline and 30 days/12 months.Change in echocardiographic and hemodynamic parameters (RV function, RA/RV dimensions, sPAP).Incidence of TVARC-defined complications (periprocedural and during follow-up).

—

Countries

Belgium, Luxembourg, Netherlands

Contacts

Public ContactM.G.H. Vrijkorte

St. Antonius Ziekenhuis

m.vrijkorte@antoniusziekenhuis.nl088 320 09 26

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)