Infective EndocarditisIESCOPHONCT05253469
Infective Endocarditis Surgery Using Conventional Prosthetic Valves Versus Cryopreserved Aortic Homograft
An observational study of Infective Endocarditis and Heart Failure, run by Centre Cardiologique du Nord at 1 site in France.
Trial summary
: 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Infective Endocarditis, Heart Failure
- What is being tested?
- Cryopreserved Aortic Homograft, Stented/Non stented xenograft and Mechanical prostheses
- Type of treatment
- Surgery or procedure
- How many people
- 760 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2005to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Pediatric
- Any echocardiographic evidence of absence of IE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cryopreserved Aortic Homograft Versus Conventional Prosthetic Valves for Infective Endocarditis Involving the Aortic Valve : a Propensity Score Matched Analysis
: 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)
Read the detailed description
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.
- Conditions
- Infective Endocarditis, Heart Failure
- Being tested
- Cryopreserved Aortic Homograft, Stented/Non stented xenograft, Mechanical prostheses
- Keywords
- IE ; CAH ; AVRpl ; Root replacement; Intervalvular fibrosa
- Medical subject headings
- Endocarditis, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryopreserved Aortic HomograftProcedure or surgery
Also called Root replacement, Commando procedure, Emicommando procedure
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
Stented/Non stented xenograftProcedure or surgery
Also called Root replacement, Commando procedure, Emicommando procedure
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
Mechanical prosthesesProcedure or surgery
Also called Root replacement, Commando procedure
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Cryopreserved Aortic Homograft; Procedure: Stented/Non stented xenograft; Procedure: Mechanical prostheses | |
| 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. Receives: Procedure: Cryopreserved Aortic Homograft; Procedure: Stented/Non stented xenograft; Procedure: Mechanical prostheses | |
| 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 Receives: Procedure: Cryopreserved Aortic Homograft; Procedure: Stented/Non stented xenograft; Procedure: Mechanical prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
The primary end point of the study is the degree of treatment failure as assessed by death, recurrent aortic valve regurgitation and reoperation
Measured: 10 years]
Secondary outcomes (9)
Overall Mortality
The secondary endpoint of the study is the evaluation of overall mortality
Measured: 10 years
Cardiac Death
The secondary endpoint of the study is the evaluation of cardiac death
Measured: 10 years
Non Cardiac Death
The secondary endpoint of the study is the evaluation of non cardiac death
Measured: 10 years
Hospitalizations for Heart Failure (HF)
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
Measured: 10 years
Major Adverse Cardiac or Cerebrovascular Events (MACCE)
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.
Measured: 10 years
Echocardiographic Parameter Changes (LVEF)
Changes from baseline parameters including left ventricular ejection fraction
Measured: 10 years
Echocardiographic Parameter Changes (recurrence)
Recurrent moderate-to-severe aortic regurgitation after intervention
Measured: 10 years
Echocardiographic Parameter Changes (LVEDD)
Changes from baseline Left Ventricular End Diastolic Diameter
Measured: 10 years
Echocardiographic Parameter Changes (Aortic Root diameter)
Changes from baseline aortic root diameter
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Jan 2005
- Primary completion30 Mar 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Cardiologique du Nord
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University, Henri Mondor University Hospital, University of Bristol, Aberdeen Royal Infirmary, University of Chieti
- Responsible party
- Principal investigator, Francesco Nappi, Centre Cardiologique du Nord
- Investigators
- Francesco Nappi, MD, Principal investigator, Centre Cardiologique du Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253469
- Sponsor's protocol ID
- CN-21-24
- Acronym
- IESCOPHO
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nappi F, Nenna A, Petitti T, Spadaccio C, Gambardella I, Lusini M, Chello M, Acar C. Long-term outcome of cryopreserved allograft for aortic valve replacement. J Thorac Cardiovasc Surg. 2018 Oct;156(4):1357-1365.e6. doi: 10.1016/j.jtcvs.2018.04.040. Epub 2018 Apr 18.
PubMed 29759737Olivito S, Lalande S, Nappi F, Hammoudi N, D'Alessandro C, Fouret P, Acar C. Structural deterioration of the cryopreserved mitral homograft valve. J Thorac Cardiovasc Surg. 2012 Aug;144(2):313-20, 320.e1. doi: 10.1016/j.jtcvs.2011.06.041. Epub 2011 Sep 8.
PubMed 21855094Nappi F, Spadaccio C, Dreyfus J, Attias D, Acar C, Bando K. Mitral endocarditis: A new management framework. J Thorac Cardiovasc Surg. 2018 Oct;156(4):1486-1495.e4. doi: 10.1016/j.jtcvs.2018.03.159. Epub 2018 Apr 13. No abstract available.
PubMed 29884490Nappi F, Spadaccio C, Acar C. Use of allogeneic tissue to treat infective valvular disease: Has everything been said? J Thorac Cardiovasc Surg. 2017 Apr;153(4):824-828. doi: 10.1016/j.jtcvs.2016.09.071. Epub 2016 Oct 24. No abstract available.
PubMed 27866779Kim JB, Ejiofor JI, Yammine M, Camuso JM, Walsh CW, Ando M, Melnitchouk SI, Rawn JD, Leacche M, MacGillivray TE, Cohn LH, Byrne JG, Sundt TM. Are homografts superior to conventional prosthetic valves in the setting of infective endocarditis involving the aortic valve? J Thorac Cardiovasc Surg. 2016 May;151(5):1239-46, 1248.e1-2. doi: 10.1016/j.jtcvs.2015.12.061. Epub 2016 Jan 23.
PubMed 26936004Sabik JF, Lytle BW, Blackstone EH, Marullo AG, Pettersson GB, Cosgrove DM. Aortic root replacement with cryopreserved allograft for prosthetic valve endocarditis. Ann Thorac Surg. 2002 Sep;74(3):650-9; discussion 659. doi: 10.1016/s0003-4975(02)03779-7.
PubMed 12238819Savage EB, Saha-Chaudhuri P, Asher CR, Brennan JM, Gammie JS. Outcomes and prosthesis choice for active aortic valve infective endocarditis: analysis of the Society of Thoracic Surgeons Adult Cardiac Surgery Database. Ann Thorac Surg. 2014 Sep;98(3):806-14. doi: 10.1016/j.athoracsur.2014.05.010. Epub 2014 Jul 29.
PubMed 25085561Nappi F, Asta L, Garufi L, Avtaar Singh SS, Benedetto U, Acar C, Fiore A. Infective endocarditis surgery using conventional prosthetic valves versus homograft: the IESCOPO study protocol. J Cardiothorac Surg. 2026 Apr 30;21(1):432. doi: 10.1186/s13019-026-04088-8.
PubMed 42063114
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryopreserved Aortic Homograft Versus Conventional Prosthetic Valves for Infective Endocarditis Involving the Aortic Valve : a Propensity Score Matched Analysis
- ClinicalTrials.gov ID
- NCT05253469
- Acronym / sponsor ID
- IESCOPHO / CN-21-24
- Conditions
- Infective Endocarditis, Heart Failure
- Keywords
- IE ; CAH ; AVRpl ; Root replacement; Intervalvular fibrosa
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Centre Cardiologique du NordUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University, Henri Mondor University Hospital, University of Bristol, Aberdeen Royal Infirmary, University of Chieti
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: 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)
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cryopreserved Aortic Homograft | – | Procedure: Cryopreserved Aortic Homograft, Procedure: Stented/Non stented xenograft, Procedure: Mechanical prosthesesInclude 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). |
| Stented/Non stented xenograft | – | Procedure: Cryopreserved Aortic Homograft, Procedure: Stented/Non stented xenograft, Procedure: Mechanical prosthesesStented/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. |
| Mechanical valve prostheses | – | Procedure: Cryopreserved Aortic Homograft, Procedure: Stented/Non stented xenograft, Procedure: Mechanical prosthesesMechanical 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pediatric
- Any echocardiographic evidence of absence of IE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryopreserved Aortic HomograftAlso: Root replacement, Commando procedure, Emicommando procedureCAH 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 | Procedure or surgery | Cryopreserved Aortic Homograft, Mechanical valve prostheses, Stented/Non stented xenograft |
| Stented/Non stented xenograftAlso: Root replacement, Commando procedure, Emicommando procedureThe 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 | Procedure or surgery | Cryopreserved Aortic Homograft, Mechanical valve prostheses, Stented/Non stented xenograft |
| Mechanical prosthesesAlso: Root replacement, Commando procedureThe 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 | Procedure or surgery | Cryopreserved Aortic Homograft, Mechanical valve prostheses, Stented/Non stented xenograft |
Primary outcome
Treatment failure
Time frame: 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
9 secondary outcomes
Overall Mortality
Time frame: 10 years
Cardiac Death
Time frame: 10 years
Non Cardiac Death
Time frame: 10 years
Hospitalizations for Heart Failure (HF)
Time frame: 10 years
Major Adverse Cardiac or Cerebrovascular Events (MACCE)
Time frame: 10 years
Echocardiographic Parameter Changes (LVEF)
Time frame: 10 years
Echocardiographic Parameter Changes (recurrence)
Time frame: 10 years
Echocardiographic Parameter Changes (LVEDD)
Time frame: 10 years
Echocardiographic Parameter Changes (Aortic Root diameter)
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Results publication: PubMed 29759737Nappi F, Nenna A, Petitti T, Spadaccio C, Gambardella I, Lusini M, Chello M, Acar C. Long-term outcome of cryopreserved allograft for aortic valve replacement. J Thorac Cardiovasc Surg. 2018 Oct;156(4):1357-1365.e6. doi: 10.1016/j.jtcvs.2018.04.040. Epub 2018 Apr 18.
- Results publication: PubMed 21855094Olivito S, Lalande S, Nappi F, Hammoudi N, D'Alessandro C, Fouret P, Acar C. Structural deterioration of the cryopreserved mitral homograft valve. J Thorac Cardiovasc Surg. 2012 Aug;144(2):313-20, 320.e1. doi: 10.1016/j.jtcvs.2011.06.041. Epub 2011 Sep 8.
- Results publication: PubMed 29884490Nappi F, Spadaccio C, Dreyfus J, Attias D, Acar C, Bando K. Mitral endocarditis: A new management framework. J Thorac Cardiovasc Surg. 2018 Oct;156(4):1486-1495.e4. doi: 10.1016/j.jtcvs.2018.03.159. Epub 2018 Apr 13. No abstract available.
- Results publication: PubMed 27866779Nappi F, Spadaccio C, Acar C. Use of allogeneic tissue to treat infective valvular disease: Has everything been said? J Thorac Cardiovasc Surg. 2017 Apr;153(4):824-828. doi: 10.1016/j.jtcvs.2016.09.071. Epub 2016 Oct 24. No abstract available.
- Results publication: PubMed 26936004Kim JB, Ejiofor JI, Yammine M, Camuso JM, Walsh CW, Ando M, Melnitchouk SI, Rawn JD, Leacche M, MacGillivray TE, Cohn LH, Byrne JG, Sundt TM. Are homografts superior to conventional prosthetic valves in the setting of infective endocarditis involving the aortic valve? J Thorac Cardiovasc Surg. 2016 May;151(5):1239-46, 1248.e1-2. doi: 10.1016/j.jtcvs.2015.12.061. Epub 2016 Jan 23.
- Results publication: PubMed 12238819Sabik JF, Lytle BW, Blackstone EH, Marullo AG, Pettersson GB, Cosgrove DM. Aortic root replacement with cryopreserved allograft for prosthetic valve endocarditis. Ann Thorac Surg. 2002 Sep;74(3):650-9; discussion 659. doi: 10.1016/s0003-4975(02)03779-7.
- Results publication: PubMed 25085561Savage EB, Saha-Chaudhuri P, Asher CR, Brennan JM, Gammie JS. Outcomes and prosthesis choice for active aortic valve infective endocarditis: analysis of the Society of Thoracic Surgeons Adult Cardiac Surgery Database. Ann Thorac Surg. 2014 Sep;98(3):806-14. doi: 10.1016/j.athoracsur.2014.05.010. Epub 2014 Jul 29.
- Derived from this study: PubMed 42063114Nappi F, Asta L, Garufi L, Avtaar Singh SS, Benedetto U, Acar C, Fiore A. Infective endocarditis surgery using conventional prosthetic valves versus homograft: the IESCOPO study protocol. J Cardiothorac Surg. 2026 Apr 30;21(1):432. doi: 10.1186/s13019-026-04088-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Nappi, MD principal investigator
Centre Cardiologique du Nord
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Endocarditis and Heart Failure, run by Centre Cardiologique du Nord at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 10 years]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05253469, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.