Aortic Valve StenosisNCT04056832
Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve
A study testing Single Strip Pericardium and Mechanical Prosthetic Valve in people with Aortic Valve Stenosis and Aortic Stenosis, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Stenosis, Valve Stenoses, Aortic
- What is being tested?
- Single Strip Pericardium and Mechanical Prosthetic Valve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndonesia
- Study dates
- 20 Apr 2017to 20 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo Central National Hospital
Jakarta, DKI Jakarta, 10430
Ismail Dilawar, doctor, +6281310567075, ismail_dilawar@yahoo.com
About this study
Official title: Left Ventricular Reverse Remodeling in Aortic Valve Replacement With Single Strip Pericardium and Mechanical Valve: A Comparative Study
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.
Read more
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.
- Conditions
- Aortic Valve Stenosis, Aortic Stenosis, Valve Stenoses, Aortic, Aortic Valve Calcification
- Being tested
- Single Strip Pericardium, Mechanical Prosthetic Valve
- Keywords
- Aortic Stenosis, Aortic Valve Replacement, Single Strip Pericardium, Autologous Pericardium, Mechanical Valve Replacement, Comparison of Left Ventricle Remodeling
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve, Calcification of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Strip PericardiumProcedure or surgery
Also called Autologous 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.
Mechanical Prosthetic ValveProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Strip Pericardium | Experimental | Aortic Valve Replacement using single strip of patient's autologous pericardium Receives: Procedure: Single Strip Pericardium |
| Mechanical Prosthetic Valve | Active comparator | Aortic Valve Replacement using mechanical prosthetic valve Receives: Procedure: Mechanical Prosthetic Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular End Diastolic Diameter
Left Ventricular End Diastolic Diameter in mili meters assessed by Trans-thoracic Echocardiography measurement on M-mode
Measured: before surgery, 3 months and 6 months after surgery
Change in Left Ventricular End Systolic Diameter
Left Ventricular End Systolic Diameter in mili meters assessed by Trans-thoracic Echocardiography measurement on M-mode
Measured: before surgery, 3 months and 6 months after surgery
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)
Measured: before surgery, 3 months and 6 months after surgery
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
Measured: before surgery, 3 months and 6 months after surgery
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
Measured: before surgery, 3 months and 6 months after surgery
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
Measured: before surgery, 3 months and 6 months after surgery
Secondary outcomes (11)
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
Measured: at the time of surgery
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
Measured: at the time of surgery
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
Measured: before surgery
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
Measured: before surgery
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)
Measured: before surgery
Aortic Regurgitation Severity
Aortic Regurgitation Severity classified as mild, moderate, and severe based on Recommendations from American Society of Echocardiography
Measured: before surgery
Number of Valve Replacement and/or Repair
Number of valves being replaced and/or repaired
Measured: at the time of surgery
Aortic Cross Clamp Time in minute
The time from Aortic Cross Clamp On to Cross Clamp Off
Measured: at the time of surgery
Surgery Time in minute
The time from first incision to finished closing surgical wound
Measured: at the time of surgery
Cardiopulmonary Bypass Time in minute
The time from begin Cardiopulmonary Bypass (CPB) On to CPB Off
Measured: at the time of surgery
Duration of Hospitalization
Number of days of Hospitalization since admission date to discharge date
Measured: at the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start20 Apr 2017
- Primary completion20 Jan 2020 (estimated)
- Study completion20 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ismail Dilawar, doctor, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056832
- Sponsor's protocol ID
- 011
- Other IDs
- ETIKUI-1612576
- Status last verified
- Aug 2019
- First submitted
- 1 Feb 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21149862Coffey 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.
PubMed 26541169Osnabrugge 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.
PubMed 23727214Maganti 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.
PubMed 20435842
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Reverse Remodeling in Aortic Valve Replacement With Single Strip Pericardium and Mechanical Valve: A Comparative Study
- ClinicalTrials.gov ID
- NCT04056832
- Acronym / sponsor ID
- 011
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 20 Jan 2020 (estimated)
- Study completion
- 20 Apr 2020 (estimated)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Strip Pericardium | Experimental | Procedure: Single Strip PericardiumAortic Valve Replacement using single strip of patient's autologous pericardium |
| Mechanical Prosthetic Valve | Active comparator | Procedure: Mechanical Prosthetic ValveAortic Valve Replacement using mechanical prosthetic valve |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Strip PericardiumAlso: Autologous PericardiumThe 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. | Procedure or surgery | Single Strip Pericardium |
| Mechanical Prosthetic ValveMedian 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. | Procedure or surgery | Mechanical Prosthetic Valve |
Primary outcome
Change in Left Ventricular End Diastolic Diameter
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
11 secondary outcomes
Coaptation Height of Aortic Valve Leaflet in mili meters
Time frame: at the time of surgery
Effective Height of Aortic Valve in mili meters
Time frame: at the time of surgery
Aortic Jet Velocity Value in m/s
Time frame: before surgery
Mean Trans-aortic Pressure Gradient Value in mmHg
Time frame: before surgery
Aortic Stenosis Severity
Time frame: before surgery
Aortic Regurgitation Severity
Time frame: before surgery
Number of Valve Replacement and/or Repair
Time frame: at the time of surgery
Aortic Cross Clamp Time in minute
Time frame: at the time of surgery
Surgery Time in minute
Time frame: at the time of surgery
Cardiopulmonary Bypass Time in minute
Time frame: at the time of surgery
Duration of Hospitalization
Time frame: at the time of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Results publication: PubMed 21149862d'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.
- Results publication: PubMed 26541169Coffey 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 publication: PubMed 23727214Osnabrugge 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 publication: PubMed 20435842Maganti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail Dilawar, doctor principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Strip Pericardium and Mechanical Prosthetic Valve in people with Aortic Valve Stenosis and Aortic Stenosis, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ismail Dilawar, doctor (+6281310567075, ismail_dilawar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular End Diastolic Diameter (time frame: before surgery, 3 months and 6 months after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04056832, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.