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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03552679
Other study ID # WT/aj/MEC-2018-1162
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 24, 2018
Est. completion date July 2021

Study information

Verified date October 2019
Source Erasmus Medical Center
Contact Osama SOLIMAN, MD, PhD
Phone +31643158470
Email osoliman@eurohf.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date July 2021
Est. primary completion date February 2021
Accepts healthy volunteers
Gender All
Age group 17 Years and older
Eligibility Inclusion Criteria:

Subjects to be included in the study must meet the following inclusion criteria:

1. Consecutive patients accepted for elective LVAD implantation in the context of routine care

2. >17 years of age

3. Written informed consent (IC), either by the patient or by legal representatives

4. Treated with mainstream devices

Exclusion Criteria:

- None

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Echocardiography
Echocardiography

Locations

Country Name City State
Germany Herz- und Diabeteszentrum Nordrhein- Westfalen Bad Oeynhausen
Germany Deutsches Herzzentrum Berlin Berlin
Hungary Heart Center of the Semmelweis University Budapest
Italy S. Orsola Hospital, Bologna University Bologna
Italy Ospedale dei Colli Naples
Kazakhstan National Research Cardiac Surgery Center Astana
Netherlands Erasmus Medical Center Rotterdam
Turkey Ege University School of Medicine Izmir
United Kingdom Euromacs, Eacts Windsor

Sponsors (2)

Lead Sponsor Collaborator
Erasmus Medical Center The European Association for Cardio-Thoracic Surgery

Countries where clinical trial is conducted

Germany,  Hungary,  Italy,  Kazakhstan,  Netherlands,  Turkey,  United Kingdom, 

References & Publications (1)

Soliman OII, Akin S, Muslem R, Boersma E, Manintveld OC, Krabatsch T, Gummert JF, de By TMMH, Bogers AJJC, Zijlstra F, Mohacsi P, Caliskan K; EUROMACS Investigators. Derivation and Validation of a Novel Right-Sided Heart Failure Model After Implantation of Continuous Flow Left Ventricular Assist Devices: The EUROMACS (European Registry for Patients with Mechanical Circulatory Support) Right-Sided Heart Failure Risk Score. Circulation. 2018 Feb 27;137(9):891-906. doi: 10.1161/CIRCULATIONAHA.117.030543. Epub 2017 Aug 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Moderate or severe RHF RHF is defined by a triad of:
Clinical (right-sided congestion, with or without hypotension, or hypo-perfusion)
Imaging evidence (RV dilatation, new > grade 2 tricuspid regurgitation) deterioration right ventricular function score assessed by the echocardiography core laboratory)
Hemodynamic evidence (discordant elevated central venous pressure (CVP) or right atrial pressure (RAP) >16 mmHg, despite normal or steady pulmonary capillary wedge pressure (PCWP), or right atrial (RA) to PCWP ratio >0.54).
12 months
Secondary Severe RHF composite The occurrence of Severe RHF composite after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary All-cause death The occurrence of all-cause death after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary Cardiovascular death The occurrence of cardiovascular death after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary Death or urgent transplantation The occurrence of death or urgent transplantation after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary Length of post-operative Intensive Care Unit (ICU) stay The length of post-operative ICU stay in days after LVAD implantation 30 days, 90 days, 180 days, 12 months
Secondary Length of post-operative hospital stay The length of post-operative hospital stay in days after LVAD implantation 30 days, 90 days, 180 days, 12 months
Secondary Readmissions for heart failure or RHF The occurrence of hospital readmissions for heart failure or RHF after LVAD implantation 30 days, 90 days, 180 days, 12 months
Secondary Sepsis The occurrence of sepsis after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary LVAD and driveline-related infection The occurrence of LVAD and driveline-related infection after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary Early and late bleeding complications The occurrence of LVAD and driveline-related infection after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary LVAD pump thrombosis The occurrence of LVAD and driveline-related infection after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary Haemolysis The occurrence of LVAD and driveline-related infection after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary Arterial thromboembolic events, including stroke The occurrence of LVAD and driveline-related infection after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary Venous thromboembolic events, including deep venous thrombosis (DVT) and pulmonary embolism (PE) The occurrence of LVAD and driveline-related infection after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary Ventricular arrhythmias, either sustained symptomatic or with appropriate Implantable Cardioverter Defibrillator (ICD) therapy The occurrence of LVAD and driveline-related infection after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary Atrial arrhythmias - documented atrial flutter or fibrillation The occurrence of LVAD and driveline-related infection after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary Acute Kidney Injury (AKI) according to Kidney Disease Outcomes Quality Initiative (KDIGO) and RIFFLE criteria The occurrence of LVAD and driveline-related infection after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary Chronic kidney disease (CKD) according to KDOQI criteria The occurrence of Chronic kidney disease (CKD) according to KDOQI criteria after LVAD implantation 1 week, 30 days, 90 days, 180 days, 12 months
Secondary Six Minute walk distance in meters Assessment of Six Minute walk distance in meters before and after LVAD implantation 90 days and 12 months
Secondary Quality of life (QoL) scores QoL by multiple assessments before and at 90 days, 180 days and at 12 months after LVAD implantation at 90 days, 180 days and at 12 months
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