Serial Multiparametric Evaluation of Right Ventricular Function After Left Ventricular Assist Device Implantation

Right Heart Failure Clinical Trial

— EuroEchoVAD  

Official title:

A Prospective, Multicenter, Observational, Investigator Initiated Study, Aiming at Serial Multiparametric Evaluation of Right Ventricular Function to Predict Optimal Management Strategies, of Right Heart Failure After LVAD Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03552679
• Other study ID #: WT/aj/MEC-2018-1162
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Heart Failure
• Right Heart Failure

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