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Chirurgia infekcyjnego zapalenia wsierdzia przy użyciu konwencjonalnych protez zastawek w porównaniu z kriokonserwowanym homoprzeszczepem aorty (IESCOPHO)

27 września 2026 zaktualizowane przez: Francesco Nappi, Centre Cardiologique du Nord

Kriokonserwowany homoprzeszczep aorty w porównaniu z konwencjonalnymi protezami zastawek w leczeniu infekcyjnego zapalenia wsierdzia obejmującego zastawkę aortalną: analiza dopasowania wyniku skłonności

: 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)

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

760

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 90 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: COHORT
  • Perspektywy czasowe: PROSPECTIVE

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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

Inne nazwy:
  • Wymiana korzenia
  • Procedura komandosów
  • Procedura emikomandosów

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

Inne nazwy:
  • Wymiana korzenia
  • Procedura komandosów
  • Procedura emikomandosów

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

Inne nazwy:
  • Wymiana korzenia
  • Procedura komandosów
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

Inne nazwy:
  • Wymiana korzenia
  • Procedura komandosów
  • Procedura emikomandosów

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

Inne nazwy:
  • Wymiana korzenia
  • Procedura komandosów
  • Procedura emikomandosów

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

Inne nazwy:
  • Wymiana korzenia
  • Procedura komandosów
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

Inne nazwy:
  • Wymiana korzenia
  • Procedura komandosów
  • Procedura emikomandosów

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

Inne nazwy:
  • Wymiana korzenia
  • Procedura komandosów
  • Procedura emikomandosów

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

Inne nazwy:
  • Wymiana korzenia
  • Procedura komandosów

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Treatment failure
Ramy czasowe: 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]

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Overall Mortality
Ramy czasowe: 10 years

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

10 years
Cardiac Death
Ramy czasowe: 10 years

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

10 years
Non Cardiac Death
Ramy czasowe: 10 years

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

10 years
Hospitalizations for Heart Failure (HF)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 10 years

Changes from baseline parameters including left ventricular ejection fraction

10 years
Echocardiographic Parameter Changes (recurrence)
Ramy czasowe: 10 years

Recurrent moderate-to-severe aortic regurgitation after intervention

10 years
Echocardiographic Parameter Changes (LVEDD)
Ramy czasowe: 10 years

Changes from baseline Left Ventricular End Diastolic Diameter

10 years
Echocardiographic Parameter Changes (Aortic Root diameter)
Ramy czasowe: 10 years

Changes from baseline aortic root diameter

10 years

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Treatment failure
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Śledczy

  • Główny śledczy: Francesco Nappi, MD, Centre Cardiologique du Nord

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 stycznia 2005

Zakończenie podstawowe (Szacowany)

30 marca 2027

Ukończenie studiów (Szacowany)

1 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

14 lutego 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 lutego 2022

Pierwszy wysłany (Rzeczywisty)

23 lutego 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

30 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • CN-21-24

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .