Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI

CompletedOBSERVATIONAL
Enrollment

21

Participants

Timeline

Start Date

May 8, 2024

Primary Completion Date

June 13, 2024

Study Completion Date

July 13, 2024

Conditions
Aortic Valve Stenosis
Interventions
DIAGNOSTIC_TEST

Determination of arterial compliance using blood pressure waveform analysis

Measurement of arterial stiffness using a non-invasive pressure transducer placed on the skin of the wrist, which records the pulse wave at the level of the radial artery in order to analyze the characteristics of the arterial wall. The parameters of interest are the arterial stiffness of large- and small-caliber arteries (ml/mmHg).

DIAGNOSTIC_TEST

Measurement of plasma Vascular Endothelium Growth Factor

Measurement of plasma Vascular Endothelium Growth Factor levels by ELISA

DIAGNOSTIC_TEST

Skin temperature gradient

Measurement of skin surface temperature gradient, defined as the difference in temperature between the skin surface of the forearm and that of the fingertip (forearm-to-fingertip)

DIAGNOSTIC_TEST

Vaso-occlusion test

Measurement of endothelial function by a vaso-occlusion test performed by inflating a cuff on the arm to occlude arterial flow for 3 min. Reactive hyperemia on deflation of the cuff is measured by photoplethysmography placed on the index finger, and tissue oxygen saturation (StO2) by near-infrared spectroscopy (NIRS). The amplitude of the reperfusion flow corresponding to the peak of the perfusion index (ΔPI Peak) and the time to reach this peak (time to peak) are the parameters recorded by photoplethysmography. Tissue resaturation rate (rStO2) is the parameter recorded by NIRS.

DIAGNOSTIC_TEST

Transthoracic echocardiography

The diameter of the left ventricular outflow tract is measured in the tele systolic parasternal long-axis view. The pulsed Doppler flow profile is acquired at the level of the left ventricular chamber in the apical five-chamber view. The time-velocity integral of the aortic flow is then calculated. Left ventricular end-diastolic and end-systolic volumes are also measured using Simpson's method in the 4-cavity monoplane view. Measurements of vena cava diameter and respiratory variability of vena cava diameter provide an estimate of right atrial pressure. These measurements estimate cardiac output and systemic vascular resistance.

DIAGNOSTIC_TEST

Photoplethysmography

The perfusion index (PI) is derived from the signal and represents the ratio between the absorbance or reflectance of pulsatile and non-pulsatile light of the photoplethysmography signal. PI is measured non-invasively using a photoplethysmographic sensor placed on the earlobe or finger.

PROCEDURE

Transcatheter aortic valve insertion (TAVI)

TAVI is a treatment for aortic valve stenosis. A new valve is inserted with minimally invasive procedure without removing the old, damaged valve.

Trial Locations (1)

1211

Prof Karim Bendjelid, Geneva

All Listed Sponsors
collaborator

Stanislas Abrard

UNKNOWN

collaborator

Noble Stéphane

UNKNOWN

lead

University Hospital, Geneva

OTHER

NCT06154642 - Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI | Biotech Hunter | Biotech Hunter