Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve

University of Indonesia (UI)

Status: Unknown

Conditions: Aortic Valve Stenosis; Valve Stenoses, Aortic; Aortic Stenosis; Aortic Valve Calcification

Treatments: Procedure: Mechanical Prosthetic Valve; Procedure: Single Strip Pericardium

Study type: Interventional

Funder types: Other

Identifiers

NCT04056832

011

ETIKUI-1612576 (Other Identifier)

Details and patient eligibility

About

Aortic stenosis is a commonly found heart disease, which often leads to mortality and morbidity. Valve replacement using mechanical prosthetic valve will have an expensive cost especially in the Integrated Heart Center of Cipto Mangunkusumo Hospital, Jakarta, Indonesia. In addition to the expensive cost, patients who have mechanical prosthetic valve have an increased risk of infection of the prosthetic valve and developing thrombo-embolism thus have to consume a lifelong anticoagulant therapy that increase risk of bleeding. A surgical technique using autologous pericardium is an alternative to prosthetic valve replacement, one of which is a single pericardium strip technique that uses modified autologous pericardium technique from Ozaki et al and Duran et al.

The objective of this study is to investigate the outcome of aortic valve replacement with a single pericardium strip of autologous pericardium in patients with aortic stenosis.

This study will be conducted at the Integrated Heart Center of Cipto Mangunkusumo Hospital, Jakarta, Indonesia, by using quasi experimental type time series design. Subjects are patients with aortic stenosis who are candidates for valve replacement. Inclusion criteria is having low to moderate surgical risk (EuroScore II <5). The sampling method used in this study is non-probability consecutive sampling. This study will assess the outcome of the aortic valve replacement (valve hemodynamic, left ventricular reverse remodelling, sST2, 6MWT) at 3 months and 6 months post-aortic valve replacement.

It is expected that aortic valve replacement using a single strip of autologous pericardium will have good valve hemodynamic outcome, yield left ventricular reverse remodelling, decrease sST2 level, show upgrade in 6MWT, and have shorter aortic cross clamp time so that it can be an alternative to aortic valve replacement using mechanical prosthetic valve that is less expensive and have good outcomes in patient with aortic stenosis.

Enrollment: 62 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged more than 10 years old
• Patients with aortic valve stenosis with an indication of aortic valve replacement having low to moderate surgical risk (EuroScore II <5)
• The patient or guardian (the research subject's parent) agrees to follow the study

Exclusion criteria

• Patients who have previously underwent aortic valve replacement
• Patients with aortic stenosis due to bicuspid aortic valve
• Patients with autoimmune disease
• Patients with mixed connective tissue disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Single Strip Pericardium

Experimental group

Description:

Aortic Valve Replacement using single strip of patient's autologous pericardium

Treatment:

Procedure: Single Strip Pericardium

Mechanical Prosthetic Valve

Active Comparator group

Description:

Aortic Valve Replacement using mechanical prosthetic valve

Treatment:

Procedure: Mechanical Prosthetic Valve