Status:
COMPLETED
Sedation or General Anesthesia During TAVR
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Stenoses, Aortic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Transcatheter aortic valve replacement TAVR is become the reference method for patients with severe aortic stenosis who are contraindicated or at risk for surgical aortic replacement. Initially perfor...
Detailed Description
Implantation of a femoral percutaneous aortic prosthesis (TAVI) has become a routine therapy for elderly patients with severe aortic stenosis (SA) and a high or intermediate surgical risk. With growin...
Eligibility Criteria
Inclusion
- Patients over 18 years of age
- Consecutive patients referred to the cardiology department of the CHU in Montpellier, France, for TAVI via transfemoral access.
- Patients for whom the procedure is indicated after decision by the heart team and according to the current recommendations of the European Society of Cardiology.
- Patients with severe aortic stenosis defined by mean gradient \> 40 mmHg and/or aortic valve area 1 cm2 or 0.8 cm2/m2 as recommended. May also include patients with low gradient (\< 40mm hg) and low flow (stroke volume index \< 35ml/minute) which are classic indications for aortic valve replacement
- Ability to consent to participate in study
- Patient affiliated with or beneficiary of a social security scheme
Exclusion
- Chronic respiratory insufficiency treated by long term oxygeno therapy
- Pulmonary hypertension above 50mmHg
- BMI\>35
- TAVI by carotidian or apical way
- Pregnant women
- Vulnerable person according to L1121-6 of Public Health reglementation in France
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2024
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT04347603
Start Date
December 8 2020
End Date
March 20 2024
Last Update
September 30 2025
Active Locations (2)
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1
University hospital
Montpellier, France
2
University hospital
Nîmes, France