PRELOAD-TAVI Trial

TAVI Clinical Trial

— PRELOAD-TAVI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05914051
• Other study ID #: PRELOAD-TAVI
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: June 2023
• Source: Fundación de investigación HM
• Contact: Leire Unzue, PhD
• Phone: 0034917089900
• Email: leireunzue[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• TAVI

Intervention

Other:
• Colloid preload
250 cc of colloid preload solution will be infused in the intervention group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación de investigación HM

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Need of inotropes	Yes/no	"1 year"
Other	HR after TAVI	rpm	"1 year"
Primary	Cardiac output after valve implant	Cardiac output (l/min) after TAVI	"1 year"
Secondary	Stroke volume after valve implant	SV (ml) after TAVI	"1 year"