Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve
Primary Purpose
Aortic Valve Stenosis, Aortic Stenosis, Valve Stenoses, Aortic
Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Single Strip Pericardium
Mechanical Prosthetic Valve
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic Stenosis, Aortic Valve Replacement, Single Strip Pericardium, Autologous Pericardium, Mechanical Valve Replacement, Comparison of Left Ventricle Remodeling
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
Sites / Locations
- Cipto Mangunkusumo Central National HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Single Strip Pericardium
Mechanical Prosthetic Valve
Arm Description
Aortic Valve Replacement using single strip of patient's autologous pericardium
Aortic Valve Replacement using mechanical prosthetic valve
Outcomes
Primary Outcome Measures
Change in Left Ventricular End Diastolic Diameter
Left Ventricular End Diastolic Diameter in mili meters assessed by Trans-thoracic Echocardiography measurement on M-mode
Change in Left Ventricular End Systolic Diameter
Left Ventricular End Systolic Diameter in mili meters assessed by Trans-thoracic Echocardiography measurement on M-mode
Change in Ejection Fraction Percentage
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)
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)
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
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
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
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
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
Mean Trans-aortic Pressure Gradient Value measured in mili meters Hydrargyrum (mmHg) with Bernoulli equation on Trans-thoracic Echocardiography
Aortic Stenosis Severity
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
Aortic Regurgitation Severity classified as mild, moderate, and severe based on Recommendations from American Society of Echocardiography
Number of Valve Replacement and/or Repair
Number of valves being replaced and/or repaired
Aortic Cross Clamp Time in minute
The time from Aortic Cross Clamp On to Cross Clamp Off
Surgery Time in minute
The time from first incision to finished closing surgical wound
Cardiopulmonary Bypass Time in minute
The time from begin Cardiopulmonary Bypass (CPB) On to CPB Off
Duration of Hospitalization
Number of days of Hospitalization since admission date to discharge date
Full Information
NCT ID
NCT04056832
First Posted
February 1, 2019
Last Updated
August 13, 2019
Sponsor
Fakultas Kedokteran Universitas Indonesia
1. Study Identification
Unique Protocol Identification Number
NCT04056832
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
January 20, 2020 (Anticipated)
Study Completion Date
April 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fakultas Kedokteran Universitas Indonesia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Aortic Stenosis, Valve Stenoses, Aortic, Aortic Valve Calcification
Keywords
Aortic Stenosis, Aortic Valve Replacement, Single Strip Pericardium, Autologous Pericardium, Mechanical Valve Replacement, Comparison of Left Ventricle Remodeling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Strip Pericardium
Arm Type
Experimental
Arm Description
Aortic Valve Replacement using single strip of patient's autologous pericardium
Arm Title
Mechanical Prosthetic Valve
Arm Type
Active Comparator
Arm Description
Aortic Valve Replacement using mechanical prosthetic valve
Intervention Type
Procedure
Intervention Name(s)
Single Strip Pericardium
Other Intervention Name(s)
Autologous Pericardium
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mechanical Prosthetic Valve
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Left Ventricular End Diastolic Diameter
Description
Left Ventricular End Diastolic Diameter in mili meters assessed by Trans-thoracic Echocardiography measurement on M-mode
Time Frame
before surgery, 3 months and 6 months after surgery
Title
Change in Left Ventricular End Systolic Diameter
Description
Left Ventricular End Systolic Diameter in mili meters assessed by Trans-thoracic Echocardiography measurement on M-mode
Time Frame
before surgery, 3 months and 6 months after surgery
Title
Change in Ejection Fraction Percentage
Description
Ejection Fraction Percentage assessed by Trans-thoracic Echocardiography with modified Simpson's volumetric method (BiPlane measurement: apical 4 chambers and apical 2 chambers)
Time Frame
before surgery, 3 months and 6 months after surgery
Title
Change in 6 Minute Walking Test Performance (meters)
Description
Subjects will be asked to walk for six minutes on a given track then the distance achieved will be measured in meters
Time Frame
before surgery, 3 months and 6 months after surgery
Title
Change in 6 Minute Walking Test Performance (METs)
Description
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
Time Frame
before surgery, 3 months and 6 months after surgery
Title
Change in Soluble Suppression of Tumorigenicity-2 (sST2) Level
Description
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
Time Frame
before surgery, 3 months and 6 months after surgery
Secondary Outcome Measure Information:
Title
Coaptation Height of Aortic Valve Leaflet in mili meters
Description
Aortic Valve Coaptation height measured in mili meters by Trans-oesophageal Echocardiography on mid-oesophageal long axis view
Time Frame
at the time of surgery
Title
Effective Height of Aortic Valve in mili meters
Description
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
Time Frame
at the time of surgery
Title
Aortic Jet Velocity Value in m/s
Description
Aortic Jet Velocity value measured in meters per second (m/s) by Color Wave Doppler on Trans-thoracic Echocardiography
Time Frame
before surgery
Title
Mean Trans-aortic Pressure Gradient Value in mmHg
Description
Mean Trans-aortic Pressure Gradient Value measured in mili meters Hydrargyrum (mmHg) with Bernoulli equation on Trans-thoracic Echocardiography
Time Frame
before surgery
Title
Aortic Stenosis Severity
Description
Aortic Stenosis Severity classified as mild, moderate, and severe based on Recommendations from European Association of Echocardiography and American Society of Echocardiography (EAE/ASE)
Time Frame
before surgery
Title
Aortic Regurgitation Severity
Description
Aortic Regurgitation Severity classified as mild, moderate, and severe based on Recommendations from American Society of Echocardiography
Time Frame
before surgery
Title
Number of Valve Replacement and/or Repair
Description
Number of valves being replaced and/or repaired
Time Frame
at the time of surgery
Title
Aortic Cross Clamp Time in minute
Description
The time from Aortic Cross Clamp On to Cross Clamp Off
Time Frame
at the time of surgery
Title
Surgery Time in minute
Description
The time from first incision to finished closing surgical wound
Time Frame
at the time of surgery
Title
Cardiopulmonary Bypass Time in minute
Description
The time from begin Cardiopulmonary Bypass (CPB) On to CPB Off
Time Frame
at the time of surgery
Title
Duration of Hospitalization
Description
Number of days of Hospitalization since admission date to discharge date
Time Frame
at the time of surgery
Other Pre-specified Outcome Measures:
Title
Duration of Intensive Care Unit Stay
Description
Number of hours in the Intensive Care Unit since after the surgery until subject is transferred to hospital ward
Time Frame
at the time of surgery
Title
Duration of Ventilator Use
Description
Number of hours of breathing assisted with ventilator since intubation until extubation
Time Frame
at the time of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ismail Dilawar, doctor
Phone
+6281310567075
Email
ismail_dilawar@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nusaibah N Juliafina, doctor
Phone
+6281210189732
Email
nusaibahjuliafina@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismail Dilawar, doctor
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Central National Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ismail Dilawar, doctor
Phone
+6281310567075
Email
ismail_dilawar@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21149862
Citation
d'Arcy JL, Prendergast BD, Chambers JB, Ray SG, Bridgewater B. Valvular heart disease: the next cardiac epidemic. Heart. 2011 Jan;97(2):91-3. doi: 10.1136/hrt.2010.205096. Epub 2010 Dec 13. No abstract available. Erratum In: Heart. 2011 Jul;97(13):1112.
Results Reference
result
PubMed Identifier
26541169
Citation
Coffey S, Cairns BJ, Iung B. The modern epidemiology of heart valve disease. Heart. 2016 Jan;102(1):75-85. doi: 10.1136/heartjnl-2014-307020. Epub 2015 Nov 5. No abstract available.
Results Reference
result
PubMed Identifier
23727214
Citation
Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, Bogers AJ, Piazza N, Kappetein AP. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013 Sep 10;62(11):1002-12. doi: 10.1016/j.jacc.2013.05.015. Epub 2013 May 30.
Results Reference
result
PubMed Identifier
20435842
Citation
Maganti K, Rigolin VH, Sarano ME, Bonow RO. Valvular heart disease: diagnosis and management. Mayo Clin Proc. 2010 May;85(5):483-500. doi: 10.4065/mcp.2009.0706.
Results Reference
result
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Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve
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