Minimally Invasive Mitral Valve Replacement Versus Conventional Approach: Comparison of Early Postoperative Outcomes.

Sohag University

Status: Not yet enrolling

Conditions: Minimally Invasive Mitral Valve Surgery

Treatments: Procedure: mitral valve replacement through full sternotomy approach.; Procedure: mitral valve replacement through right mini thoracotomy approach.

Study type: Interventional

Funder types: Other

Identifiers

NCT05504109

Soh-Med-22-08-12

Details and patient eligibility

About

The term minimally invasive mitral valve surgery has been reported (MIMVS) by American Heart Association and referred to a collection of new techniques. All of these new techniques aiming to reduce surgical trauma by minimizing surgical incision, modified perfusion methods and use of new instruments . The right anterior mini-thoracotomy is the most common approach, next to it the lower mini-sternotomy approach, then the parasternal incision or the left posterior thoracotomy approach .

Technically MIMVS is more complex, requires a special learning curve and associated with higher Incidence of neurological events, aortic dissection, groin complications and infection despite all these benefits . MIVS also has controversies among cardiac surgeons, because it makes the exposure worse and requires a more complex surgery, which may lead to a less satisfying effect

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with isolated rheumatic mitral valve disease in need for mitral valve replacement.

Exclusion criteria

• Redo mitral valve replacement.
• Emergency mitral valve replacement (non-rheumatic cases).
• Patients who have combined other valve diseases e.g. (severe Aortic Regurgitation).
• Patients need Tricuspid valve repair or replacement.
• Severely calcified mitral valve disease (mitral annular calcification).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Group A

Active Comparator group

Description:

patients who will undergo mitral valve replacement through full sternotomy approach

Treatment:

Procedure: mitral valve replacement through full sternotomy approach.

Group B

Active Comparator group

Description:

patients who will undergo mitral valve replacement through right mini thoracotomy approach

Treatment:

Procedure: mitral valve replacement through right mini thoracotomy approach.