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Clinical Trial Summary

The primary purpose of this study is to investigate the evolution of Right Ventricular (RV) function before and after left ventricular assist device (LVAD) implantation, using novel echocardiographic quantification of RV size and function in combination with comprehensive hemodynamic, laboratory and clinical parameters. The findings of the study will enhance prediction of early and late development of postoperative right-sided heart failure (RHF) and subsequent mortality and morbidity.

The secondary purpose of the study is to combine echocardiographic, hemodynamic, laboratory, and clinical data to define optimal management strategies of RHF after LVAD implantation.

Clinical Trial Description

The study consists of 2 parts: a Pilot study and a Main Study as detailed below.

The purpose of the Pilot study is to evaluate the feasibility of RV quantification using two-, three-dimensional and Multiplane echocardiography.

About 100 subjects undergoing LVAD implantation in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) Registry are included in the Pilot study. These 100 patients will undergo routinely scheduled echocardiography before, within 1 week, 3 months and 1 year after LVAD implantation. Echocardiography will be performed using ultrasound machines that are capable of acquisition of two-, three-dimensional and Multiplane Echocardiography of the right ventricle.

Echocardiographic analysis will include three-dimensional quantification of the RV size and function as well as RV strain analysis in the Multiplane format as described in the Appendix Echocardiography Procedure Manual.

The Echocardiographic analyses of the first 50 patients, included in selected sites, will be used to further specify the protocol for image acquisition and analysis to be used in the Main Study. Furthermore, all sites will first enter 2 patients in the Pilot Study before they can participate in the Main Study. The echocardiographic results of these 2 patients will be assessed by the core lab for quality.

The purpose of the Main Study is to assess the evolution of RV function before and after LVAD implantation utilizing the acquisition and analysis protocol developed in the Pilot Study.

500 patients will undergo routinely scheduled echocardiographic imaging before LVAD implantation, and at 1 week, 1 month, 3 months, 6 months and 1 year thereafter. Echocardiography will be performed using the detailed protocol developed in the Pilot Study. All Echocardiographic images will be submitted to an independent Core Laboratory for analysis.

The evolution of RV function will be documented with standardised two-, three-dimensional and Multiplane Echocardiography of the right ventricle. The echocardiographic parameters include: RV strain and strain rate, RV Fractional Area Change, RV longitudinal function, RV volumes, RV ejection fraction, tricuspid regurgitation severity, estimated pulmonary artery pressures, pulmonary artery resistance, pulmonary artery compliance, RV stroke work index, right atrial size, and RV - pulmonary coupling.

Invasive hemodynamic data will be collected in the perioperative period. These RV parameters will be linked to the occurrence of clinical signs, hemodynamic and laboratory evidence of RHF. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03552679
Study type Observational [Patient Registry]
Source Erasmus Medical Center
Contact Osama SOLIMAN, MD, PhD
Phone +31643158470
Status Recruiting
Start date June 2018
Completion date July 2021

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