Health Condition 1: I088- Other rheumatic multiple valve diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The patients who will undergo repeat cardiac valve replacement for a left-sided obstructive mechanical valve due to thrombus or pannus, infective endocarditis, or paravalvular leak, as recommended by the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery will be included in this study. The explanted failed old mechanical valve will be tested in a bench model after obtaining written informed consent from the patient.
Exclusion criteria
Exclusion criteria: 1 Ball and cage mechanical valve 2 Bioprosthetic valve 3 Not willing to give written informed consent 4 Right-sided valves from tricuspid and pulmonary positions 5 Serology-positive patients for HBsAg, Hepatitis C virus, or Human immunodeficiency virus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the structural changes of the mechanical heart valves namely annular fracture, leaflet fracture, leaflet dislodgement from the hinges, & leaflet deformation during 1:1 sized balloon dilatation at the rated burst pressure (RBP) in the central & lateral orifices or the minor & major orifices of the explanted mechanical valves.Timepoint: At the time of balloon dilatation | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the balloon size required for leaflet fracture or leaflet dislodgement from the hinges of the explanted mechanical valves. To describe the various pathological changes in the failed mechanical valves. To describe the clinical presentation & echocardiographic findings of the stuck valve patients. Timepoint: At the time of balloon dilatation | — |
Countries
India
Contacts
The Madras Medical Mission