NCT05253469Active, not recruiting
Infective Endocarditis Surgery Using Conventional Prosthetic Valves Versus Cryopreserved Aortic Homograft
Cryopreserved Aortic Homograft Versus Conventional Prosthetic Valves for Infective Endocarditis Involving the Aortic Valve : a Propensity Score Matched Analysis
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
: 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)
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 760 (estimated)
- First submitted
- 14 Feb 2022
- Start date
- 1 Jan 2005
- Primary completion date
- 30 Mar 2027
- Lead sponsor
- Centre Cardiologique du Nord
- Diseases
- Heart failure
- NCT number
- NCT05253469
What you commit to
- Study type: Observational
- Planned participants: 760
- From 1 Jan 2005 to the primary completion date, 30 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Pediatric
- Any echocardiographic evidence of absence of IE
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Francesco Nappi Coordinator of this site? Confirm its status | Saint-Denis | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.