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NCT05253469 · ClinicalTrials.gov record · last posted 2026-08-19

Infective Endocarditis Surgery Using Conventional Prosthetic Valves Versus Cryopreserved Aortic Homograft

Study acronym: IESCOPHO
StatusActive, Not Recruiting
PhaseNot specified
Started2005-01-01
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
: Evidence suggested that autologous or allogeneic tissue is more suitable to synthetic material in an infected field. Given the unwillingness of some surgeons to use artificial foreign materials, such as conventional mechanical or stent xenograft valve prostheses, cryopreserved aortic homografts (CAH) have been recommended revealing favorable outcomes in aortic valve endocarditis (AVE) surgery (1-5). This aspect is even more evident in cases involving prosthetic valve endocarditis (PVE) and other complex and aggressive lesions involving the aortic root and intervalvular fibrosa with abscess formation. However, most of these reports are fixed on single-arm observational studies without comparing CAH with conventional prostheses. The key question of this study is to establish the difference in treatment failure (death, recurrent aortic valve regurgitation and reoperation), all-cause and cause-specific (cardiac vs noncardiac) mortality, hospitalizations for heart failure during follow-up (structural/non structural valve deterioration, thromboembolism and recurrent endocarditis) in patients who received the CAH vs conventional mechanical or stent xenograft valve prostheses for aortic valve replacement (AVR) secondary to infective endocarditis (IE)

Protocol amendment history 3 changes detected by DataLookout

2026-08-20
notable
Trial status changed: Enrolling by Invitation → Active, Not Recruiting
2026-08-20
critical
Primary completion pushed: 2024-12-31 → 2027-03-30
2026-08-20
minor
Completion pushed: 2026-12-01 → 2028-12-01
Trial Details
NCT Number NCT05253469
Lead Sponsor Centre Cardiologique du Nord
Collaborators: Campus Bio-Medico University, Henri Mondor University Hospital, Universita degli Studi di Genova, University of Bristol, Aberdeen Royal Infirmary
Conditions Infective Endocarditis, Heart Failure
Enrollment 760 participants
Start Date 2005-01-01
Primary Completion 2027-03-30 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-19