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OpenTrials
Completed

NCT Number: NCT03464981

Observational Hemodynamic Monitoring During LVAD Implantation Among Individuals With Advanced Heart Failure

The overall objective of this pilot analysis is to characterize the hemodynamic changes that occur during implantation of a left ventricular assist device (LVAD) in patients with advanced heart failure - specifically, how right ventricular function is compromised as a result of LVAD implantation.

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Key information

Conditions

Heart Failure Cardiomegaly Cardiomyopathies Cardiomyopathy, Congestive Cardiomyopathy, Dilated Cardiovascular Diseases Circulatory Disorders Postprocedural Complication Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Laminopathies Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • individuals ≥ 18 years of age with severe heart failure (HF) and who have been approved by the advanced HF selection committee for LVAD implantation.

Exclusion criteria

  • Patients with pre-existing right ventricular (RV) dysfunction/failure, defined as:
  • Imaging evidence of moderate-severe RV dysfunction on echocardiography
  • Hemodynamic evidence of RV dysfunction with:
  • a right-atrial pressure (RAP): pulmonary capillary wedge pressure (PCWP) ratio of ≥ 0.67 (note: this index compares pressures on the right [RAP] and left [PCWP] side of the heart;
  • an RAP/PCWP ratio ≥ 0.67 provides hemodynamic evidence of RV dysfunction.
  • Clinical evidence of preexisting RV dysfunction, as indicated by significant (3-4+ peripheral edema) and/or elevated jugular venous pressures on clinical examination.
  • Patients with end-stage renal disease requiring hemodialysis
  • Patients requiring temporary hemodynamic support prior to LVAD implantation with temporary LVADs, and/or veno-arterial extracorporeal membrane oxygenators ("ECMO").
  • Planned concurrent implantation of right ventricular assist device

Treatment and study plan

Primary outcomes

  1. Change in Cardiovascular hemodynamics (invasive and noninvasive)

    Time frame: During LVAD implant and for 12-24 hours during ICU admission

    Cardiovascular hemodynamics will be measured both invasively and noninvasively as standard-of-care during LVAD implantation in the Operating Room (OR), and immediately afterwards in the CT-ICU unit prior to discharge.

  2. Change in Heart Rate (HR)

    Time frame: During LVAD implant and for 12-24 hours during ICU admission

    Changes in HR will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.

  3. Change in Blood Pressure (BP)

    Time frame: During LVAD implant and for 12-24 hours during ICU admission

    Changes in BP will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.

  4. Change in Right Atrial (RA) pressure

    Time frame: During LVAD implant and for 12-24 hours during ICU admission

    Changes in RA pressure will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.

  5. Change in pulmonary pressure

    Time frame: During LVAD implant and for 12-24 hours during ICU admission

    Pulmonary pressure changes will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.

  6. Change in Cardiac output

    Time frame: During LVAD implant and for 12-24 hours during ICU admission

    Cardiac output changes will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.

Secondary outcomes

  1. Change in Right ventricular function

    Time frame: During LVAD implant and for 12-24 hours during ICU admission

    Right ventricular function will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.

  2. Change in Brain blood flow

    Time frame: During LVAD implant and for 12-24 hours during ICU admission

    Brain blood flow will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Observational Hemodynamic Monitoring During LVAD Implantation Among

Acronym: BATMAN

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 14, 2018
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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