NCT07108803

Brief Summary

The European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis (ERGOSTE) is a nascent large surgical registry that would encompass most relevant aspects of IE in Europe in the contemporary era.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Start

First participant enrolled

June 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

July 16, 2025

Last Update Submit

August 5, 2025

Conditions

Infective Endocarditis (IE)

Keywords

Infective endocarditisCardiac surgeryOutcomesRisk scorePredictionIn-hospital mortalityPathogen agentsStatisticsSepsisSurgical techniquesEpidemiology

Outcome Measures

Primary Outcomes (1)

  • Early post-operative mortality

    Mortality at 1 year after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing cardiac surgery due to infective endocarditis

You may qualify if:

  • Patients undergoing cardiac surgery due to infective endocarditis

You may not qualify if:

  • Patients under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Surgery Unit - ASUGI

Trieste, TRIESTE, 34151, Italy

Location

MeSH Terms

Conditions

EndocarditisSepsis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
UNKNOWN
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2025

First Posted

August 7, 2025

Study Start

June 1, 2025

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations

IT(1)