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

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ClinicalTrials.gov Identifier: NCT03552679
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
The European Association for Cardio-Thoracic Surgery
Information provided by (Responsible Party):
I. Osama SOLIMAN, MD, PhD, Erasmus Medical Center

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.


Condition or disease Intervention/treatment
Right Heart Failure Diagnostic Test: Echocardiography

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
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.
Diagnostic Test: Echocardiography
Echocardiography




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Severe RHF composite [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of Severe RHF composite after LVAD implantation

  2. All-cause death [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of all-cause death after LVAD implantation

  3. Cardiovascular death [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of cardiovascular death after LVAD implantation

  4. 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

  5. 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

  6. 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

  7. 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

  8. Sepsis [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of sepsis after LVAD implantation

  9. 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

  10. 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

  11. 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

  12. Haemolysis [ Time Frame: 1 week, 30 days, 90 days, 180 days, 12 months ]
    The occurrence of LVAD and driveline-related infection after LVAD implantation

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Consecutive patients who underwent LVAD implantation using main stream devices
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552679


Contacts
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Contact: Osama SOLIMAN, MD, PhD +31643158470 o.soliman@gerasmusmc.nl
Contact: Kadir Caliskan, MD, PhD +31681268158 k.caliskan@erasmusmc.nl

Locations
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Belgium
Onze Lieve Vrouwenziekenhuis Not yet recruiting
Aalst, Belgium
Contact: Marc Vanderheyden, MD, PhD         
Principal Investigator: Marc Vanderheyden, MD, PhD         
Germany
Herz- und Diabeteszentrum Nordrhein- Westfalen Not yet recruiting
Bad Oeynhausen, Germany
Contact: Lech Paluszkiewicz, MD, PhD         
Principal Investigator: Lech Paluszkiewicz, MD, PhD         
Deutsches Herzzentrum Berlin Not yet recruiting
Berlin, Germany
Contact: Felix Schönrath, MD, PhD         
Principal Investigator: Felix Schönrath, MD, PhD         
Universitäts Herzzentrum Freiburg, Bad Krozingen Not yet recruiting
Freiburg, Germany
Contact: David Schibilsky, MD, PhD         
Principal Investigator: Friedhelm Beyersdorf, MD, PhD         
Principal Investigator: David Schibilsky, MD, PhD         
Hungary
Heart Center of the Semmelweis University Not yet recruiting
Budapest, Hungary
Contact: Béla Merkely, MD, PhD         
Principal Investigator: Béla Merkely, MD, PhD         
Italy
S. Orsola Hospital, Bologna University Not yet recruiting
Bologna, Italy
Contact: Antonio Loforte, MD, PHD         
Principal Investigator: Antonio Loforte         
Ospedale dei Colli Not yet recruiting
Naples, Italy
Contact: Cristiano Amarelli         
Principal Investigator: Cristiano Amarelli, MD, PhD         
Kazakhstan
National Research Cardiac Surgery Center Not yet recruiting
Astana, Kazakhstan
Contact: Makhabbat Bekbossynova, MD, PhD         
Principal Investigator: Makhabbat Bekbossynova, MD, PhD         
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Kadir Caliskan, MD, PhD         
Principal Investigator: Kadir Caliskan, MD, PhD         
Utrecht Medical Center Not yet recruiting
Utrecht, Netherlands
Contact: Nicolas de Jong, MD, PhD         
Principal Investigator: Nicolas de Jong, MD, PhD         
Principal Investigator: Faez Ramjankhan, MD, PhD         
Turkey
Ege University School of Medicine Not yet recruiting
İzmir, Turkey
Contact: Sanem Nalbantgil, MD, PhD         
Principal Investigator: Sanem Nalbantgil, MD, PhD         
Principal Investigator: Mustafa Özbaran, MD, PhD         
United Kingdom
Euromacs, Eacts Active, not recruiting
Windsor, United Kingdom
Sponsors and Collaborators
Erasmus Medical Center
The European Association for Cardio-Thoracic Surgery
Investigators
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Principal Investigator: Osama SOLIMAN, MD, PhD Erasmus MC Rotterdam
Principal Investigator: Kadir Caliskan, MD, PhD Erasmus MC Rotterdam

Additional Information:

Publications:
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Responsible Party: I. Osama SOLIMAN, MD, PhD, Assistant Professor of Cardiology, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03552679     History of Changes
Other Study ID Numbers: WT/aj/MEC-2018-1162
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by I. Osama SOLIMAN, MD, PhD, Erasmus Medical Center:
Right Heart Failure
Ventricular Assist Device
Mortality
ICU Stay
Acute Kidney Injury
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases