Status:
COMPLETED
Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
Stanislas Abrard
Noble Stéphane
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
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 implantat...
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 mechanism...
Eligibility Criteria
Inclusion
- All major patients undergoing a femoral TAVI procedure for severe aortic stenosis,
Exclusion
- 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.
Key Trial Info
Start Date :
May 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 13 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06154642
Start Date
May 8 2024
End Date
July 13 2024
Last Update
August 6 2024
Active Locations (1)
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1
Prof Karim Bendjelid
Geneva, Canton of Geneva, Switzerland, 1211