NCT04056832

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

Status unknown NA Last updated 14 August 2019

What this trial tests

NA trial testing Single Strip Pericardium in Aortic Valve Stenosis in 62 participants. Status unknown.

Timeline

20 April 2017

Primary endpoint
20 January 2020

20 April 2020

Quick facts

Lead sponsor	Fakultas Kedokteran Universitas Indonesia
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	20 April 2017
Primary completion	20 January 2020
Estimated completion	20 April 2020
Sites	1 location across Indonesia

Drugs / interventions tested

• Single Strip Pericardium
• Mechanical Prosthetic Valve

Conditions studied

• Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
• Aortic Stenosis — all drugs for Aortic Stenosis →
• Valve Stenoses, Aortic — all drugs for Valve Stenoses, Aortic →
• Aortic Valve Calcification — all drugs for Aortic Valve Calcification →

Sponsor

Fakultas Kedokteran Universitas Indonesia — full company profile →

Who can join

10 and older, any sex, with Aortic Valve Stenosis or Aortic Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.