An interventional study of Colloid preload in TAVI, sponsored by Fundación de investigación HM. Not yet recruiting. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Fundación de investigación HM · Not applicable, Interventional, and Treatment
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.
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.
Fundación de investigación HM is the lead sponsor of 22 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Volume overload with 250 cc saline solution will be performed in the intervention arm, verifying the response of the cardiac output and stroke volume with non invasive continue monitoring.
Other: Colloid preload
Standard care without volume preload.
250 cc of colloid preload solution will be infused in the intervention group
Cardiac output after valve implant
Cardiac output (l/min) after TAVI
Time frame: "1 year"
Stroke volume after valve implant
SV (ml) after TAVI
Time frame: "1 year"
Need of inotropes
Yes/no
Time frame: "1 year"
HR after TAVI
rpm
Time frame: "1 year"
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Fundación de investigación HM