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Clinical Trials/NCT05914051
NCT05914051Not yet recruitingNot Applicable

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

Fundación de investigación HM0 sites50 target enrollmentStarted: October 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
50
Primary Endpoint
Cardiac output after valve implant

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 110 Years (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

Cardiac output after valve implant

Time Frame: "1 year"

Cardiac output (l/min) after TAVI

Secondary Outcomes

  • Stroke volume after valve implant("1 year")

Investigators

Sponsor
Fundación de investigación HM
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Leire Unzue Vallejo

PRELOAD-TAVI Trial

Fundación de investigación HM

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