Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06154642
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2023-11-23
Brief Title:
Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Physiological Study of Hemodynamic and Microcirculatory Evolution BeforeAfter Transcatheter Aortic Valve Replacement TAVI
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAVI
Brief Summary:
The Physiological Study of Haemodynamic and Microcirculatory Evolution beforeafter 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None