Influence of Original Native Aortic Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Aortic Valve Replacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aortic valve replacement.
- Who it may be relevant to
- Registry conditions: Aortic Bioprosthesis Degeneration. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or aortic valve regurgitation at our institution from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated session) will be enrolled in the study. These patients will be contacted to provide information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and to perform a postoperative echocardiography if not performed in the previous year. Once consent is given, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.
Detailed description
All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or aortic valve regurgitation at our institution from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated session) will be enrolled in the study. These patients will be contacted to provide information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and to perform a postoperative echocardiography if not performed in the previous year. Once consent is given, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.
Interventions
- Procedure Aortic valve replacement
All operations were performed through median longitudinal sternotomy or mini-sternotomy. 8 Intraoperative transesophageal echocardiography (TOE) was used in all patients. Arterial cannulation was central and venous cannulation was achieved with a common two-stage cannula in the right atrium. Left ventricle was vented through the right superior pulmonary vein. In minimally invasive procedures, venous cannulation was achieved percutaneously. Myocardial protection was achieved by administration of
Primary outcome measures
- Prosthetic valve deterioration and degenration [Time frame: 10-15 years]
Secondary outcome measures (1)
- Survival [Time frame: 15 years]
Eligibility criteria
Inclusion criteria
- \- Age ≥ 18 years; 9
- Patients who underwent isolated aortic and mitral valve replacement for stenosis or regurgitation
- Signed informed consent, inclusive of release of medical information.
Exclusion criteria
- \- Aortic and mitral valve replacement associated with surgery of ascending aorta/aortic root;
- Aortic and mitral valve replacement associated with other cardiac valve surgery (apart from arrythmia-related ablation or procedures);
- Previous cardiac surgery of any kind;
- Surgery for acute endocarditis
- Surgery for Type A aortic dissection
- Participation in another clinical trial that could interfere with the endpoints of this study.
- Pregnant or breastfeeding at time of screening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Maastricht UMC+ METC — Maastricht
Identifiers
NCT: NCT06964035 · METC 2023-0326