Clinical trial NCT06154642: Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI
Official title: Physiological Study of Hemodynamic and Microcirculatory Evolution Before/After Transcatheter Aortic Valve Replacement (TAVI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: Transcatheter Aortic Valve Implantation
Microcirculation
Endothelium, vascular
Microvascular reactivity
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Stanislas Abrard
name: Noble Stéphane
First posted: 2023-12-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Selection from patients with severe aortic stenosis referred to the Geneva tertiary university hospital for minimally invasive procedures.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modification in arterial stiffness in large- and small-caliber arteries
timeFrame: 24 hours
measure: Modification in plasma Vascular Endothelium Growth Factor levels
timeFrame: 24 hours
measure: Modification in skin surface temperature gradient
timeFrame: 24 hours
measure: Modification in reactive hyperemia
timeFrame: 24 hours
Secondary outcomes:
measure: Organ dysfunction
timeFrame: 7 days
measure: Functional capacity
timeFrame: day 6
measure: Mortality
timeFrame: 30 days
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 30 days
measure: Major Adverse Kidney Events (MAKE)
timeFrame: 30 days
Other outcomes:
Locations:
city: Geneve
country: Switzerland
facility: Prof Karim Bendjelid
state: Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Karim Bendjelid, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: