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Infective Endocarditis Surgery Using Conventional Prosthetic Valves Versus Cryopreserved Aortic Homograft

Study acronym: IESCOPHO
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 2 months later Dec 31, 2024 → Mar 30, 2027
See other at-risk trials from Centre Cardiologique du Nord

Record History

See every version on ClinicalTrials.gov ↗

  1. Interventions: Cryopreserved Aortic Homograft (Procedure), Mechanical prostheses (Procedure), Stented/Non stented xenograft (Procedure) to Cryopreserved Aortic Homograft (Procedure), Mechanical prostheses (Procedure), Stented/Non stented xenograft (Procedure) Show 4 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 9 entries
    • Collaborators revised (5)
    • Publications: details revised at 8 of 8 entries
  2. Primary completion pushed from Dec 31, 2024 to Mar 30, 2027
    • Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Study completion pushed from Dec 1, 2026 to Dec 1, 2028
    • Site details revised
    v6
  3. Enrollment target: 800 to 760
    • Primary completion date changed from estimate of Mar 31, 2025 to Dec 31, 2024
    • Study completion date: Dec 30, 2025 to Dec 1, 2026
    • Start date: Feb 14, 2022 to Jan 1, 2005
    v5
  4. Primary completion date: Jun 30, 2024 to Mar 31, 2025
    • Study completion date: Oct 30, 2024 to Dec 30, 2025
    v4
  5. Primary completion date: Oct 30, 2023 to Jun 30, 2024
    • Study completion date: Dec 30, 2023 to Oct 30, 2024
    v3
  6. Trial status: Active, Not Recruiting to Enrolling by Invitation
    • Primary completion date: Sep 1, 2022 to Oct 30, 2023
    • Study completion date: Sep 1, 2023 to Dec 30, 2023
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
: 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)
Trial Details
NCT Number NCT05253469
Lead Sponsor Centre Cardiologique du Nord
Collaborators: Campus Bio-Medico University, Henri Mondor University Hospital, University of Bristol, Aberdeen Royal Infirmary, University of Chieti
Conditions
(from sponsor)		 Infective Endocarditis, Heart Failure
Related terms Endocarditis, Heart Failure
Enrollment 760 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov