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

Sponsor

Fakultas Kedokteran Universitas Indonesia (Other)

Overall Status

Unknown status

CT.gov ID

NCT04056832

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis Aortic Stenosis Valve Stenoses, Aortic Aortic Valve Calcification	Procedure: Single Strip Pericardium Procedure: Mechanical Prosthetic Valve	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Left Ventricular Reverse Remodeling in Aortic Valve Replacement With Single Strip Pericardium and Mechanical Valve: A Comparative Study

Actual Study Start Date :

Apr 20, 2017

Anticipated Primary Completion Date :

Jan 20, 2020

Anticipated Study Completion Date :

Apr 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Strip Pericardium Aortic Valve Replacement using single strip of patient's autologous pericardium	Procedure: Single Strip Pericardium The anterior pericardium is taken in accordance with the measurements made using an aortic annulus sizer or Ismail sizer. The diameter of the annulus valve is converted to circumference of the aortic valve according as a measure of the length of the pericardium. Measurement of aortic commissure height is done by measuring the distance between the lowest point of the valve attachment to the highest point on the commissure as a measure of pericardium width. The pericardium is immersed in 0.6% glutaraldehyde solution for 10 minutes, then rinsed and soaked with saline solution 3 times for 6 minutes each. After the pericardium becomes firm it is cut to be a single strip according to the length and width in the previous measurement. It is then sutured to the aortic valve annulus. Other Names: Autologous Pericardium
Active Comparator: Mechanical Prosthetic Valve Aortic Valve Replacement using mechanical prosthetic valve	Procedure: Mechanical Prosthetic Valve Median incision is performed at the surgical site. Sternal retractor is placed at the sternum after median sternotomy being performed. Aortic valve is measured using aortic annulus sizer. Pledgeted suture is performed for the mattress. Sutures are performed to attach the mechanical prosthetic to the aortic annulus.

Arm

Intervention/Treatment

Experimental: Single Strip Pericardium

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

Procedure: Single Strip Pericardium

The anterior pericardium is taken in accordance with the measurements made using an aortic annulus sizer or Ismail sizer. The diameter of the annulus valve is converted to circumference of the aortic valve according as a measure of the length of the pericardium. Measurement of aortic commissure height is done by measuring the distance between the lowest point of the valve attachment to the highest point on the commissure as a measure of pericardium width. The pericardium is immersed in 0.6% glutaraldehyde solution for 10 minutes, then rinsed and soaked with saline solution 3 times for 6 minutes each. After the pericardium becomes firm it is cut to be a single strip according to the length and width in the previous measurement. It is then sutured to the aortic valve annulus.

Other Names:

Autologous Pericardium

Active Comparator: Mechanical Prosthetic Valve

Aortic Valve Replacement using mechanical prosthetic valve

Procedure: Mechanical Prosthetic Valve

Median incision is performed at the surgical site. Sternal retractor is placed at the sternum after median sternotomy being performed. Aortic valve is measured using aortic annulus sizer. Pledgeted suture is performed for the mattress. Sutures are performed to attach the mechanical prosthetic to the aortic annulus.

Outcome Measures

Primary Outcome Measures

Change in Left Ventricular End Diastolic Diameter [before surgery, 3 months and 6 months after surgery]
Left Ventricular End Diastolic Diameter in mili meters assessed by Trans-thoracic Echocardiography measurement on M-mode
Change in Left Ventricular End Systolic Diameter [before surgery, 3 months and 6 months after surgery]
Left Ventricular End Systolic Diameter in mili meters assessed by Trans-thoracic Echocardiography measurement on M-mode
Change in Ejection Fraction Percentage [before surgery, 3 months and 6 months after surgery]
Ejection Fraction Percentage assessed by Trans-thoracic Echocardiography with modified Simpson's volumetric method (BiPlane measurement: apical 4 chambers and apical 2 chambers)
Change in 6 Minute Walking Test Performance (meters) [before surgery, 3 months and 6 months after surgery]
Subjects will be asked to walk for six minutes on a given track then the distance achieved will be measured in meters
Change in 6 Minute Walking Test Performance (METs) [before surgery, 3 months and 6 months after surgery]
The result of distance in meters of the six minute walking test will be converted to VO2max by the given formula: (distance in meters x 0.03) + 3.98 = VO2max Then the VO2max will be converted to METs by given formula: VO2max : 3.5 = METs
Change in Soluble Suppression of Tumorigenicity-2 (sST2) Level [before surgery, 3 months and 6 months after surgery]
Level of soluble Suppression of Tumorigenicity-2 measured in nano gram per mili Liters (ng/mL) by quantitative sandwich enzyme immunoassay technique assessed with Quantikinine Elisa

Secondary Outcome Measures

Coaptation Height of Aortic Valve Leaflet in mili meters [at the time of surgery]
Aortic Valve Coaptation height measured in mili meters by Trans-oesophageal Echocardiography on mid-oesophageal long axis view
Effective Height of Aortic Valve in mili meters [at the time of surgery]
Effective Height of Aortic Valve measured in mili meters from Aortic annulus to the highest point of Aortic Valve coaptation by Trans-oesophageal Echocardiography in mid-oesophageal long axis view
Aortic Jet Velocity Value in m/s [before surgery]
Aortic Jet Velocity value measured in meters per second (m/s) by Color Wave Doppler on Trans-thoracic Echocardiography
Mean Trans-aortic Pressure Gradient Value in mmHg [before surgery]
Mean Trans-aortic Pressure Gradient Value measured in mili meters Hydrargyrum (mmHg) with Bernoulli equation on Trans-thoracic Echocardiography
Aortic Stenosis Severity [before surgery]
Aortic Stenosis Severity classified as mild, moderate, and severe based on Recommendations from European Association of Echocardiography and American Society of Echocardiography (EAE/ASE)
Aortic Regurgitation Severity [before surgery]
Aortic Regurgitation Severity classified as mild, moderate, and severe based on Recommendations from American Society of Echocardiography
Number of Valve Replacement and/or Repair [at the time of surgery]
Number of valves being replaced and/or repaired
Aortic Cross Clamp Time in minute [at the time of surgery]
The time from Aortic Cross Clamp On to Cross Clamp Off
Surgery Time in minute [at the time of surgery]
The time from first incision to finished closing surgical wound
Cardiopulmonary Bypass Time in minute [at the time of surgery]
The time from begin Cardiopulmonary Bypass (CPB) On to CPB Off
Duration of Hospitalization [at the time of surgery]
Number of days of Hospitalization since admission date to discharge date

Other Outcome Measures

Duration of Intensive Care Unit Stay [at the time of surgery]
Number of hours in the Intensive Care Unit since after the surgery until subject is transferred to hospital ward
Duration of Ventilator Use [at the time of surgery]
Number of hours of breathing assisted with ventilator since intubation until extubation

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts 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