Left Ventricular Reverse Remodeling In Aortic Valve Replacement With

Status Recruiting

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04056832
Study type	Interventional
Source	Fakultas Kedokteran Universitas Indonesia
Contact	Ismail Dilawar, doctor
Phone	+6281310567075
Email	ismail_dilawar@yahoo.com
Status	Recruiting
Phase	N/A
Start date	April 20, 2017
Completion date	April 20, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03186339` - Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
Recruiting	`NCT03549559` - Imaging Histone Deacetylase in the Heart	N/A
Terminated	`NCT02854319` - REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System	N/A
Recruiting	`NCT05601453` - The ReTAVI Prospective Observational Registry
Withdrawn	`NCT05481814` - CPX in Paradoxical Low Flow Aortic Stenosis
Completed	`NCT02241109` - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity	N/A
Completed	`NCT01700439` - Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve	N/A
Recruiting	`NCT04429035` - SLOW-Slower Progress of caLcificatiOn With Vitamin K2	N/A
Completed	`NCT04103931` - Impact of a Patient Decision Aid for Treatment of Aortic Stenosis	N/A
Completed	`NCT03950440` - Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Active, not recruiting	`NCT02661451` - Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)	N/A
Completed	`NCT02792452` - Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
Completed	`NCT02758964` - Evaluation of Cerebral Thrombembolism After TAVR
Completed	`NCT02847546` - Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation	N/A
Not yet recruiting	`NCT02541877` - Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve	Phase 3
Not yet recruiting	`NCT02536703` - Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population	Phase 3
Not yet recruiting	`NCT02221921` - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI	N/A
Completed	`NCT02249000` - BIOVALVE - I / II Clincial Investigation	N/A
Active, not recruiting	`NCT02080299` - Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation	Phase 2
Terminated	`NCT01939678` - Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms