Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552679
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
The European Association for Cardio-Thoracic Surgery
Information provided by (Responsible Party):
I. Osama SOLIMAN, Erasmus Medical Center

Tracking Information
First Submitted Date May 27, 2018
First Posted Date June 12, 2018
Last Update Posted Date October 11, 2019
Actual Study Start Date June 24, 2018
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 8, 2018)
Moderate or severe RHF [ Time Frame: 12 months ]
RHF is defined by a triad of:
  1. Clinical (right-sided congestion, with or without hypotension, or hypo-perfusion)
  2. Imaging evidence (RV dilatation, new > grade 2 tricuspid regurgitation) deterioration right ventricular function score assessed by the echocardiography core laboratory)
  3. 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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03552679 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 8, 2018)
  • Severe RHF composite [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of Severe RHF composite after LVAD implantation
  • All-cause death [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of all-cause death after LVAD implantation
  • Cardiovascular death [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of cardiovascular death after LVAD implantation
  • Death or urgent transplantation [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of death or urgent transplantation after LVAD implantation
  • Length of post-operative Intensive Care Unit (ICU) stay [ Time Frame: 30 days, 90 days, 180 days, 12 months ]
    The length of post-operative ICU stay in days after LVAD implantation
  • Length of post-operative hospital stay [ Time Frame: 30 days, 90 days, 180 days, 12 months ]
    The length of post-operative hospital stay in days after LVAD implantation
  • Readmissions for heart failure or RHF [ Time Frame: 30 days, 90 days, 180 days, 12 months ]
    The occurrence of hospital readmissions for heart failure or RHF after LVAD implantation
  • Sepsis [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of sepsis after LVAD implantation
  • LVAD and driveline-related infection [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of LVAD and driveline-related infection after LVAD implantation
  • Early and late bleeding complications [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of LVAD and driveline-related infection after LVAD implantation
  • LVAD pump thrombosis [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of LVAD and driveline-related infection after LVAD implantation
  • Haemolysis [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of LVAD and driveline-related infection after LVAD implantation
  • Arterial thromboembolic events, including stroke [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of LVAD and driveline-related infection after LVAD implantation
  • Venous thromboembolic events, including deep venous thrombosis (DVT) and pulmonary embolism (PE) [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of LVAD and driveline-related infection after LVAD implantation
  • Ventricular arrhythmias, either sustained symptomatic or with appropriate Implantable Cardioverter Defibrillator (ICD) therapy [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of LVAD and driveline-related infection after LVAD implantation
  • Atrial arrhythmias - documented atrial flutter or fibrillation [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of LVAD and driveline-related infection after LVAD implantation
  • Acute Kidney Injury (AKI) according to Kidney Disease Outcomes Quality Initiative (KDIGO) and RIFFLE criteria [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of LVAD and driveline-related infection after LVAD implantation
  • Chronic kidney disease (CKD) according to KDOQI criteria [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of Chronic kidney disease (CKD) according to KDOQI criteria after LVAD implantation
  • Six Minute walk distance in meters [ Time Frame: 90 days and 12 months ]
    Assessment of Six Minute walk distance in meters before and after LVAD implantation
  • Quality of life (QoL) scores [ Time Frame: 90 days, 180 days and at 12 months ]
    QoL by multiple assessments before and at 90 days, 180 days and at 12 months after LVAD implantation at
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Serial Multiparametric Evaluation of Right Ventricular Function After Left Ventricular Assist Device Implantation
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
Brief 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.

Detailed 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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Consecutive patients who underwent LVAD implantation using main stream devices
Condition Right Heart Failure
Intervention Diagnostic Test: Echocardiography
Echocardiography
Study Groups/Cohorts LVAD recipients
Consecutive patients accepted for elective LVAD implantation in the context of routine care, will undergo routinely scheduled echocardiography before, within 1 week, 1 month, 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. Invasive hemodynamic data will be collected in the perioperative period.
Intervention: Diagnostic Test: Echocardiography
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 8, 2018)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Osama SOLIMAN, MD, PhD +31643158470 osoliman@eurohf.org
Contact: Kadir Caliskan, MD, PhD +31681268158 k.caliskan@erasmusmc.nl
Listed Location Countries Germany,   Hungary,   Italy,   Kazakhstan,   Netherlands,   Turkey,   United Kingdom
Removed Location Countries Belgium
 
Administrative Information
NCT Number NCT03552679
Other Study ID Numbers WT/aj/MEC-2018-1162
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party I. Osama SOLIMAN, Erasmus Medical Center
Study Sponsor Erasmus Medical Center
Collaborators The European Association for Cardio-Thoracic Surgery
Investigators
Principal Investigator: Osama SOLIMAN, MD, PhD Euro Heart Foundation
Principal Investigator: Kadir Caliskan, MD, PhD Erasmus MC Rotterdam
PRS Account Erasmus Medical Center
Verification Date October 2019