Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06154642
Other study ID # 2023-01118
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 8, 2024
Est. completion date July 13, 2024

Study information

Verified date June 2024
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Physiological Study of Haemodynamic and Microcirculatory Evolution before/after Transcatheter Aortic Valve Replacement (TAVI) aims to investigate the physiological changes induced by the implantation of a prosthetic aortic valve on blood vessels in patients with severe aortic stenosis. The hypothesis of the study is that adaptive microcirculatory phenomena occur during TAVI implantation. The results of preoperative assessment of microcirculatory functional reserve differ according to whether or not organ dysfunction occurs after TAVI. There is a progressive adaptation of the microcirculation to the new cardiovascular load conditions after TAVI. Early features of this adaptation are associated with the occurrence of short- and medium-term complications.


Description:

This is a prospective, physiologic, monocentric, pilot cohort study carried out at the University Hospitals of Geneva on the initiative of the investigator. We are investigating the adaptive mechanisms at work in the blood vessels and their potential impact on clinical outcomes in the month following surgery. In addition to the usual perioperative monitoring, patients enrolled in the study will benefit from vascular monitoring, which consists of a series of additional non-invasive and painless examinations performed before, a few hours after and on the day after surgery. The clinical outcome of the aortic valve implantation will be monitored by a questionnaire on the day after the procedure, a 6-minute walk test during the usual consultation with the cardiologist on the 6th day after the procedure, and a review of patient health events one month after the valve implantation.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date July 13, 2024
Est. primary completion date June 13, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All major patients undergoing a femoral TAVI procedure for severe aortic stenosis, Exclusion Criteria: - Non-femoral approach for TAVI implantation, - Presence of other concomitant severe valve disease, - Planned procedure under general anesthesia, - Anticipated inability to perform a 6-minute walk test post-operatively (physical handicap), - Heart failure with left ventricular ejection fraction <40%, - Chronic end-stage renal failure, - Chronic lung disease with home oxygen therapy, - Acquired changes in serum VEGF levels: recent myocardial infarction or stroke, recent vascular intervention (< 3 months), active cancer, anti-angiogenic immunotherapy, - Patients with known or identified cognitive disorders, - Persons deprived of their liberty, persons under protective supervision, - Pregnant or breast-feeding.

Study Design


Related Conditions & MeSH terms


Intervention

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).
Measurement of plasma Vascular Endothelium Growth Factor
Measurement of plasma Vascular Endothelium Growth Factor levels by ELISA
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)
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 (?PI 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.
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.
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.

Locations

Country Name City State
Switzerland Prof Karim Bendjelid Geneve Geneva

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Geneva Noble Stéphane, Stanislas Abrard

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modification in arterial stiffness in large- and small-caliber arteries Change in arterial stiffness of large/small caliber arteries between preoperative and postoperative measurements. 24 hours
Primary Modification in plasma Vascular Endothelium Growth Factor levels Change in plasma Vascular Endothelium Growth Factor levels between preoperative and postoperative measurements. 24 hours
Primary Modification in skin surface temperature gradient Change in 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) 24 hours
Primary Modification in reactive hyperemia Change in reactive hyperemia induced by vaso-occlusion test measured by peak of the perfusion index (?PI Peak), the time to reach the peak (time to peak), and the tissue resaturation rate (rStO2). 24 hours
Secondary Organ dysfunction Organ dysfunction: Composite including one of the following events:
Acute Kidney Injury (KDIGO classification 1 and above),
Acute lung injury (measured or estimated arterial oxygen pressure / inspired oxygen fraction ratio <200),
Postoperative cardiovascular failure (need for vasopressor or inotropic support for more than 2 hours),
Postoperative neurocognitive impairment assessed using the 3D-Confusion Assessment Method
7 days
Secondary Functional capacity Distance covered in a 6-minute walk test and percentage of predicted distance day 6
Secondary Mortality All causes mortality 30 days
Secondary Major Adverse Cardiovascular Events (MACE) Composite:
Acute myocardial infarction, unstable angina, postoperative high-sensitivity troponin (= 65 ng/L),
Stroke (including transient),
Death of cardiovascular origin.
30 days
Secondary Major Adverse Kidney Events (MAKE) Composite:
Dependence on renal replacement therapy,
Decrease in glomerular filtration rate to <75% of baseline,
All causes mortality.
30 days
See also
  Status Clinical Trial Phase
Completed NCT03186339 - Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
Recruiting NCT03549559 - Imaging Histone Deacetylase in the Heart N/A
Terminated NCT02854319 - REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System N/A
Recruiting NCT05601453 - The ReTAVI Prospective Observational Registry
Withdrawn NCT05481814 - CPX in Paradoxical Low Flow Aortic Stenosis
Completed NCT02241109 - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity N/A
Completed NCT01700439 - Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve N/A
Recruiting NCT04429035 - SLOW-Slower Progress of caLcificatiOn With Vitamin K2 N/A
Completed NCT04103931 - Impact of a Patient Decision Aid for Treatment of Aortic Stenosis N/A
Completed NCT03950440 - Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Active, not recruiting NCT02661451 - Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) N/A
Completed NCT02792452 - Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
Completed NCT02758964 - Evaluation of Cerebral Thrombembolism After TAVR
Completed NCT02847546 - Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation N/A
Not yet recruiting NCT02536703 - Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Phase 3
Not yet recruiting NCT02541877 - Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve Phase 3
Completed NCT02249000 - BIOVALVE - I / II Clincial Investigation N/A
Not yet recruiting NCT02221921 - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI N/A
Active, not recruiting NCT02080299 - Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation Phase 2
Terminated NCT01939678 - Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease