ClinicalTrials.gg
CompletedNCT03464981BATMANUpdated Sep 25, 2020

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

An observational study in Heart Failure, Circulatory Disorders Postprocedural Complication and Cardiomyopathy, Congestive, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-25.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 21 studies in Heart Failure by University of Colorado, Denver — 2 open to participants now, 8 under way, none of them phase 3. Heart Failure · University of Colorado, Denver.

Started
2018
with 1 other
Observational
5 of 21
none open now
Registered
11th of 21
by date

Among the 21 studies in Heart Failure by University of Colorado, Denver, this one is one of 2 that started in 2018, is one of 5 observational ones, and was the 11th registered.

Heart Failure

6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.

Browse Heart Failure studies →

Open to participants now

2 of the 21 studies in Heart Failure by University of Colorado, Denver are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 21 studies in Heart Failure by University of Colorado, Denver, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Heart Failure
  • Circulatory Disorders Postprocedural Complication
  • Cardiomyopathy, Congestive
  • Surgery
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with advanced HF who are scheduled to undergo LVAD implantation with either the Heartmate 2, Heartmate 3 (Abbott, Abbott Park, IL) or HVAD (Medtronic, Minneapolis, MD) LVADs

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with pre-existing right ventricular (RV) dysfunction/failure, defined as:

    1. Imaging evidence of moderate-severe RV dysfunction on echocardiography
    2. 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.
    3. Clinical evidence of preexisting RV dysfunction, as indicated by significant (3-4+ peripheral edema) and/or elevated jugular venous pressures on clinical examination.
    4. Patients with end-stage renal disease requiring hemodialysis
    5. Patients requiring temporary hemodynamic support prior to LVAD implantation with temporary LVADs, and/or veno-arterial extracorporeal membrane oxygenators ("ECMO").
    6. Planned concurrent implantation of right ventricular assist device
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Advanced HF patients scheduled to undergo LVAD implantation
06

What researchers measure

Primary outcomes

  1. Change in Cardiovascular hemodynamics (invasive and noninvasive)

    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.

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

  2. Change in Heart Rate (HR)

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

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

  3. Change in Blood Pressure (BP)

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

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

  4. Change in Right Atrial (RA) pressure

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

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

  5. Change in pulmonary pressure

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

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

  6. Change in Cardiac output

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

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

Secondary outcomes

  1. Change in Right ventricular function

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

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

  2. Change in Brain blood flow

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

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

07

Study locations

1 site
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in Jun 2020, 20 months.

Of 794 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's 20 months is below that.

Counting every sponsor, half of 976 studies reached it within 41 months; a quarter within 23 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2018
First posted
Mar 14, 2018
StartActual
Sep 10, 2018
Primary completionActual
Jun 1, 2020
CompletionActual
Jul 1, 2020
Last update
Sep 25, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03464981
Responsible party
Sponsor
First posted
Mar 14, 2018
Start date
Sep 10, 2018
Primary completion
Jun 1, 2020
Completion
Jul 1, 2020
Last update
Sep 25, 2020

Study contacts

Jay D Pal, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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