Enrolling by invitation NCT07151989

Influence of Original Native Mitral Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Mitral Valve Replacement

— Observational Degeneration Mitral Bioprosthesis

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: Mitral valve replacement.
Who it may be relevant to: Registry conditions: Degeneration Mitral Bioprosthesis. 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

It aims to perform a retrospective, multi-center, observational study. All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.

Detailed description

Interventions

Procedure Mitral valve replacement
All operations were performed through median longitudinal sternotomy or mini-sternotomy. 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 c

Primary outcome measures

Prosthesis degeneration due to physiological deterioration [Time frame: 20 years]

Secondary outcome measures (1)

Long term survival [Time frame: 20 years]

Eligibility criteria

Inclusion criteria

Age ≥ 18 years;
Patients who underwent isolated mitral valve replacement for stenosis or regurgitation
Signed informed consent, inclusive of release of medical information where required by local governance.

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+ — Maastricht

Identifiers

NCT: NCT07151989 · METC 2023-0324-A-1

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗