Brief Title
Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve
Official Title
Left Ventricular Reverse Remodeling in Aortic Valve Replacement With Single Strip Pericardium and Mechanical Valve: A Comparative Study
Brief Summary
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.
Study Type
Interventional
Primary Outcome
Change in Left Ventricular End Diastolic Diameter
Secondary Outcome
Coaptation Height of Aortic Valve Leaflet in mili meters
Condition
Aortic Valve Stenosis
Intervention
Single Strip Pericardium
Study Arms / Comparison Groups
Single Strip Pericardium
Description: Aortic Valve Replacement using single strip of patient's autologous pericardium
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
62
Start Date
April 20, 2017
Completion Date
April 20, 2020
Primary Completion Date
January 20, 2020
Eligibility Criteria
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
Gender
All
Ages
10 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ismail Dilawar, doctor, +6281310567075, [email protected]
Location Countries
Indonesia
Location Countries
Indonesia
Administrative Informations
NCT ID
NCT04056832
Organization ID
011
Secondary IDs
ETIKUI-1612576
Responsible Party
Sponsor
Study Sponsor
Fakultas Kedokteran Universitas Indonesia
Study Sponsor
Ismail Dilawar, doctor, Principal Investigator, Fakultas Kedokteran Universitas Indonesia
Verification Date
August 2019