Observational Hemodynamic Monitoring During LVAD Implantation Among Individuals With Advanced Heart Failure
NCT ID: NCT03464981
Last Updated: 2020-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
20 participants
OBSERVATIONAL
2018-09-10
2020-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure
NCT00551681
Cardiac Output in Heart Failure Patients With Mechanical Pumps
NCT05195931
InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's
NCT03232736
3D Assessment of RV Function in Patients Undergoing LVAD Implantation
NCT05376254
Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
NCT03247829
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Advanced HF patients scheduled to undergo LVAD implantation
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Colorado, Denver
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jay D Pal, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Colorado Hospital
Aurora, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17-2119
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.