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

NCT04056832 | Unknown DMC

• 2 other identifiers: 011ETIKUI-1612576
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• Change in Left Ventricular End Diastolic Diameter

  Left Ventricular End Diastolic Diameter in mili meters assessed by Trans-thoracic Echocardiography measurement on M-mode

  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

  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)

  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

  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

  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

  before surgery, 3 months and 6 months after surgery

Secondary Outcomes (11)

• Coaptation Height of Aortic Valve Leaflet in mili meters

  at the time of surgery

• Effective Height of Aortic Valve in mili meters

  at the time of surgery

• Aortic Jet Velocity Value in m/s

  before surgery

• Mean Trans-aortic Pressure Gradient Value in mmHg

  before surgery

• Aortic Stenosis Severity

  before surgery

Other Outcomes (2)

• Duration of Intensive Care Unit Stay

  at the time of surgery

• Duration of Ventilator Use

  at the time of surgery

Study Arms (2)

Single Strip Pericardium

EXPERIMENTAL

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

Procedure: Single Strip Pericardium

Mechanical Prosthetic Valve

ACTIVE COMPARATOR

Aortic Valve Replacement using mechanical prosthetic valve

Procedure: Mechanical Prosthetic Valve

Interventions

Single Strip Pericardium PROCEDURE

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.

Also known as: Autologous Pericardium

Single Strip Pericardium

Mechanical Prosthetic Valve PROCEDURE

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.

Mechanical Prosthetic Valve

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

RECRUITING

Related Publications (4)

• 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.

  PMID: 21149862 RESULT

• 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.

  PMID: 26541169 RESULT

• 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.

  PMID: 23727214 RESULT

• 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.

  PMID: 20435842 RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve, Calcification of

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Ismail Dilawar, doctor

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ismail Dilawar, doctor

CONTACT

+6281310567075; ismail_dilawar@yahoo.com

Nusaibah N Juliafina, doctor

CONTACT

+6281210189732; nusaibahjuliafina@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: August 14, 2019
• Study Start: April 20, 2017
• Primary Completion: January 20, 2020
• Study Completion: April 20, 2020
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)