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Cirurgia de endocardite infecciosa usando válvulas protéticas convencionais versus homoenxerto aórtico criopreservado (IESCOPHO)

27 de setembro de 2026 atualizado por: Francesco Nappi, Centre Cardiologique du Nord

Homoenxerto aórtico criopreservado versus válvulas protéticas convencionais para endocardite infecciosa envolvendo a válvula aórtica: uma análise combinada de pontuação de propensão

: 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)

Visão geral do estudo

Descrição detalhada

The target population enrolled in the study includes patients with aortic-valve endocarditis at risk of embolization, heart failure and uncontrolled infection undergoing AVR with the use of CAH or conventional mechanical or stent xenograft valve prostheses. Individuals were adequately treated per applicable standards, including for the treatment of infection, LV dysfunction and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV.

Three groups of patients are included in the study. Patients who were managed with CAH, patients who received AVR with conventional stented xenograft and recipients of AVR undergoing surgery with the use of mechanical prostheses.

Tipo de estudo

Observacional

Inscrição (Estimado)

760

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • France
      • Saint-Denis, France, França, 93200
        • Francesco Nappi

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 90 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

Adults with aortic valve endocarditis with or without infection extending to other heart structures who were symptomatic of congestive heart failure and unresponsive to medical therapy and who were eligible for surgical aortic valve replacement. The severity of AMR was assessed by transthoracic echocardiography, performed using the European Society of Echocardiography criteria.

Descrição

Inclusion Criteria:

  • Duke Criteria
  • Uncontrolled Infection Local abscess Large vegetation False aneurysm, Fistula, Dehiscence of PV
  • Embolism Large vegetation >10mm, persistent infection
  • Heart Failure Involvement of aortic root, intervalvular fibrosa, pulmonary edema, cardiogenic shock

Exclusion Criteria :

  • Pediatric
  • Any echocardiographic evidence of absence of IE

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: COHORT
  • Perspectivas de Tempo: PROSPECTIVE

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Cryopreserved Aortic Homograft

Include patients who received CAH for native (NVE) or prosthetic valve endocarditis (PVE).

The CAH are implanted using miniroot procedure. For extended aortic valve infection, aortic root replacement and reconstruction of regional contiguity is the recommended approach. Complicated aortic IE may present with destruction of a large portion of the aortic annulus, annular abscess and colonization of infected foci in contiguous cardiac structures (eg. Aortic root and intervalvular fibrosa).

Use of homograft in first time aortic valve replacement for IE decreased over time (9,4% to 5,6%) and in reoperation (37,5% to 28,5%) in a report from STS database between 2005-2011 (6). Nevertheless, the homograft was used more often in reoperations than in primary interventions (32.2% vs 7.0%, p < 0.0001) in both valve replacements (14,6%) and for root replacements (53,2%) (6).

CAH is used for aortic root reconstruction and for repair of mitro-aortic curtain (emicommando procedure) and it is inserted as miniroot . In cases of PVE the infected prosthesis is removed with aggressive debridement of all infected and necrotic tissue. (7)The coronary ostia are prepared for reconstruction of aortic root. In complex valve endocarditis involving aortic and mitral valve a double homograft may be used.Mitro-aortic endocarditis intervalvular fibrosa is largely involved.The abscess cavity is precisely bounded and debrided. and a double homograft is used for the reconstruction (commando procedure

Outros nomes:
  • Substituição de raiz
  • Procedimento de comando
  • Procedimento Emicomando

The insertion of stented/non stented xenograft may be performed using separate or continuos stich with or without teflon pledget. Biological valves may be implated alone or combined with polyester or pericardial patch when reconstruction of annulus is required. In cases of aggressive lesions requiring root and /or intervalvular fibrosa reconstruction the choice of prosthetic bioroot using bioprosthetic valve is considered acceptable alternatives to CAH although it should be guided by the surgeon's experience

Outros nomes:
  • Substituição de raiz
  • Procedimento de comando
  • Procedimento Emicomando

The insertion of conventional mechanical valves may be performed using separate or continuos stich with or without teflon pledget. Mechanical prostheses may be implated alone or combined with polyester or pericardial patch when reconstruction of annulus is required. In cases of aggressive lesions requiring root and /or intervalvular fibrosa reconstruction the choice of prosthetic valved conduit with a mechanical valve is considered acceptable alternatives to CAH although it should be guided by the surgeon's experience

Outros nomes:
  • Substituição de raiz
  • Procedimento de comando
Stented/Non stented xenograft

Stented/Non stented xenograft may be inserted using separate or continuos stich with or without teflon pledget. The use of biological valves increased from 57% to 67% for primary the operation during which the use of mechanical valves decreased from 30% to 24%. For reoperations, the use of biologic valves increased from 38% to 52% compared to the warning use of mechanical valves from 20% to 17%. A homograft was used in only 2.5% of valve replacements, while a biological valve was used in 68.7% of the cases. This trend is reversed both in NVE and PVE the aortic root was involved (6). In the presence of peri-annular abscess formation and mitro-aortic discontinuity, conventional stented /non stented xenograft are used in combination with synthetic patch for both NVE and PVE.

CAH is used for aortic root reconstruction and for repair of mitro-aortic curtain (emicommando procedure) and it is inserted as miniroot . In cases of PVE the infected prosthesis is removed with aggressive debridement of all infected and necrotic tissue. (7)The coronary ostia are prepared for reconstruction of aortic root. In complex valve endocarditis involving aortic and mitral valve a double homograft may be used.Mitro-aortic endocarditis intervalvular fibrosa is largely involved.The abscess cavity is precisely bounded and debrided. and a double homograft is used for the reconstruction (commando procedure

Outros nomes:
  • Substituição de raiz
  • Procedimento de comando
  • Procedimento Emicomando

The insertion of stented/non stented xenograft may be performed using separate or continuos stich with or without teflon pledget. Biological valves may be implated alone or combined with polyester or pericardial patch when reconstruction of annulus is required. In cases of aggressive lesions requiring root and /or intervalvular fibrosa reconstruction the choice of prosthetic bioroot using bioprosthetic valve is considered acceptable alternatives to CAH although it should be guided by the surgeon's experience

Outros nomes:
  • Substituição de raiz
  • Procedimento de comando
  • Procedimento Emicomando

The insertion of conventional mechanical valves may be performed using separate or continuos stich with or without teflon pledget. Mechanical prostheses may be implated alone or combined with polyester or pericardial patch when reconstruction of annulus is required. In cases of aggressive lesions requiring root and /or intervalvular fibrosa reconstruction the choice of prosthetic valved conduit with a mechanical valve is considered acceptable alternatives to CAH although it should be guided by the surgeon's experience

Outros nomes:
  • Substituição de raiz
  • Procedimento de comando
Mechanical valve prostheses

Mechanical prostheses may be inserted using separate or continuos stich with or without teflon pledget. Prior to 2000, mechanical valves were used in 50% of patients compared to 14% since 2009. Analysis of the STS Database (6) showed that from 2005 to 2011 a progressive shift in favour of biological valves both as the primary operation (NVE) (73%) and in the reoperation (PVE) (27%) compared to mechanical prosthesis. For extended aortic valve infection, aortic root replacement and reconstruction of regional contiguity is the recommended approach. Complicated aortic IE may present with destruction of a large portion of the aortic annulus, annular abscess and colonization of infected foci in contiguous cardiac structures (eg. aortic root and intervalvular fibrosa). In the presence of peri-annular abscess formation and mitro-aortic discontinuity, conventional mechanical prostheses are used in combination with synthetic patch for both NVE and PVE

CAH is used for aortic root reconstruction and for repair of mitro-aortic curtain (emicommando procedure) and it is inserted as miniroot . In cases of PVE the infected prosthesis is removed with aggressive debridement of all infected and necrotic tissue. (7)The coronary ostia are prepared for reconstruction of aortic root. In complex valve endocarditis involving aortic and mitral valve a double homograft may be used.Mitro-aortic endocarditis intervalvular fibrosa is largely involved.The abscess cavity is precisely bounded and debrided. and a double homograft is used for the reconstruction (commando procedure

Outros nomes:
  • Substituição de raiz
  • Procedimento de comando
  • Procedimento Emicomando

The insertion of stented/non stented xenograft may be performed using separate or continuos stich with or without teflon pledget. Biological valves may be implated alone or combined with polyester or pericardial patch when reconstruction of annulus is required. In cases of aggressive lesions requiring root and /or intervalvular fibrosa reconstruction the choice of prosthetic bioroot using bioprosthetic valve is considered acceptable alternatives to CAH although it should be guided by the surgeon's experience

Outros nomes:
  • Substituição de raiz
  • Procedimento de comando
  • Procedimento Emicomando

The insertion of conventional mechanical valves may be performed using separate or continuos stich with or without teflon pledget. Mechanical prostheses may be implated alone or combined with polyester or pericardial patch when reconstruction of annulus is required. In cases of aggressive lesions requiring root and /or intervalvular fibrosa reconstruction the choice of prosthetic valved conduit with a mechanical valve is considered acceptable alternatives to CAH although it should be guided by the surgeon's experience

Outros nomes:
  • Substituição de raiz
  • Procedimento de comando

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Treatment failure
Prazo: 10 years]

The primary end point of the study is the degree of treatment failure as assessed by death, recurrent aortic valve regurgitation and reoperation

10 years]

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Mortality
Prazo: 10 years

The secondary endpoint of the study is the evaluation of overall mortality

10 years
Cardiac Death
Prazo: 10 years

The secondary endpoint of the study is the evaluation of cardiac death

10 years
Non Cardiac Death
Prazo: 10 years

The secondary endpoint of the study is the evaluation of non cardiac death

10 years
Hospitalizations for Heart Failure (HF)
Prazo: 10 years

The secondary endpoint of the study is the evaluation of hospedalization rates for heart failure valve due to structural/non structural valve deterioration, thromboembolism and recurrent endocarditis

10 years
Major Adverse Cardiac or Cerebrovascular Events (MACCE)
Prazo: 10 years

Composite of major adverse cardiac or cerebrovascular events (rate of death, stroke, subsequent mitral valve surgery, hospitalization for heart failure, or an increase in New York Heart Association class higher than one), serious adverse events, recurrent aortic regurgitation, quality of life, and rehospitalization.

10 years
Echocardiographic Parameter Changes (LVEF)
Prazo: 10 years

Changes from baseline parameters including left ventricular ejection fraction

10 years
Echocardiographic Parameter Changes (recurrence)
Prazo: 10 years

Recurrent moderate-to-severe aortic regurgitation after intervention

10 years
Echocardiographic Parameter Changes (LVEDD)
Prazo: 10 years

Changes from baseline Left Ventricular End Diastolic Diameter

10 years
Echocardiographic Parameter Changes (Aortic Root diameter)
Prazo: 10 years

Changes from baseline aortic root diameter

10 years

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Treatment failure
Prazo: 10 years

The primary end point of the study is the degree of treatment failure as assessed by death, recurrent aortic valve regurgitation and reoperation

10 years
A comparison of the incidence of reinfection in allogeneic substitutes and xenograft bioprostheses
Prazo: 10 years

New tracers may improve diagnostic accuracy, especially for high-risk patients.¹ Antibiotics target bacteria, making them excellent candidates for molecular imaging. The aim of this study is to identify new, selective radiopharmaceuticals for PET and SPECT applications.

10 years
To assess the occurrence of reinfection in allogeneic substitutes and mechanical prostheses.
Prazo: 10 years

A model was used to predict how a tracer would move across a tissue sample. The model included several types of movement, like convection, diffusion, binding to bacteria, and vascular washout. The model also included spatial variations in bacterial density, tissue permeability, and perfusion to estimate how much of the tracer would penetrate the tissue, how much would be retained, and how much would be in the background. The effects of diffusion, binding affinity, and clearance on the predicted tracer distribution were evaluated.

10 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Francesco Nappi, MD, Centre Cardiologique du Nord

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2005

Conclusão Primária (Estimado)

30 de março de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

14 de fevereiro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de fevereiro de 2022

Primeira postagem (Real)

23 de fevereiro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • CN-21-24

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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