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PRELOAD-TAVI Trial

PRELOAD TAVI Trial: Prospective Randomized Trial of Volume Preload Optimization in Patients With Severe Aortic Stenosis Treated on Spontaneous Breathing With Transfemoral TAVI

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05914051
Acronym
PRELOAD-TAVI
Enrollment
50
Registered
2023-06-22
Start date
2023-10-01
Completion date
2024-07-01
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TAVI

Brief summary

The aim is to assess the response of cardiac output and stroke volume to volume preload optimization in patients with severe aortic stenosis treated with aortic prosthesis implantation.

Detailed description

Patients with severe aortic stenosis present a maintained overload pressure of the left ventricle that can lead to a progressive hypertrophy. This results in elevated left-sided filling pressures and impaired diastolic function.In this context, paradoxical changes in left ventricular function after aortic valve replacement have been described, with acute decrease of the afterload condition that can result in the development of a dynamic intraventricular gradient, especially in the presence of small ventricles with severe hypertrophy, resulting in hemodynamic collapse. In this setting, it is particularly important to ensure accurate left ventricular preload to optimize myocardial contractility and guarantee an adequate hemodynamic response to valve implantation. Patients with severe aortic stenosis submitted for transfemoral TAVI on spontaneous breathing will be randomly assigned 1:1 to standard care vs volume preload optimization. Non-invasive continuous monitoring (Clear Sight System, Edwards Lifesciences) will be used to evaluate the cardiac output and the stroke volume in both groups, comparing the hemodynamics before and after valve implant.

Interventions

250 cc of colloid preload solution will be infused in the intervention group

Sponsors

Fundación de investigación HM
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No

Inclusion criteria

* Aortic valve stenosis with echocardiographic derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of \< 0.8 cm2

Exclusion criteria

* Cardiogenic shock. * Life expectancy \< 1 year. * Need of mechanic ventilation.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac output after valve implant1 yearCardiac output (l/min) after TAVI

Secondary

MeasureTime frameDescription
Stroke volume after valve implant1 yearSV (ml) after TAVI

Other

MeasureTime frameDescription
Need of inotropes1 yearYes/no
HR after TAVI1 yearrpm

Contacts

Primary ContactLeire Unzue, PhD
leireunzue@yahoo.es0034917089900
Backup ContactMiguel Rodríguez del Río, MD
mrrio1980@gmail.com0034917089900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026