Sedation or General Anesthesia During TAVR
Key facts
- Who runs it
- University Hospital, Montpellier
- Where
- France2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 218 people enrolled
- Started
- 8 Dec 2020
- Ended
- 20 Mar 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- TAVR
- Record updated
- 30 September 2025
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 performed under general anesthesia (GA), recent developpement of minimalist approach of TAVR include the use of local anesthesia (LA) with or without conscious sedation (CS) associated with full percutaneous access and no routine transoesophageal echocardiography (T0E). The aim is to simplify the procedure and to allow fast recovery of patients with early discharge and reduced cost.
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Evidence guiding the decision of whether to perform TAVR under GA or LA-CS is limited to non-randomized trials and registry data Current evidence is however limited by probable patient selection bias, methodological variability between studies, various methods of anesthesia and a lack of agreement regarding appropriate clinical end-points. The potential benefits of TAVR with LA include reduced procedure time, shorter intensive care unit (ICU) length of stay, reduced need for intraprocedural vasopressor support, and the potential to perform the procedure without the direct presence of an anesthetist for cost-saving reasons. As LA with CS is preferred with good results in main centers, GA may be useful to facilitate intraprocedural TOE which is necessary in case of intraprocedural complications and may facilitate the procedure for the physician particularly when the patient is anxious or disturbed. A resulted better concentration without precipitation may influence the outcomes in term of valve positioning. The patient comfort could also be better during femoral puncture or rapid pacing. The aim of the study is to compare transfemoral TAVR under general anesthesia (experimental group) versus local anaesthesia with sedation (control group) with a safety primary combined end point of adverse events at 72 h follow-up (hemodynamic parameters and VARC 3 criteria). Secondary end points include hospitalization length, satisfaction of the patients and operators and 30 days mortality.
The hypothesis is a non inferoirity of the GA staregy regarding the primary end point.
The 2 groups in the trial
- General AnesthesiaTreatment being tested
\- General anesthesia : After pre-anesthetic preparation (25-50 mg Hydroxizine orally), the anesthesia induction will be performed by IV perfusion of Propofol 1 to 2 mg/kg, Sufentanyl for analgesia 0,2 to 0,4 µg/kg, curarisation with Atracurium 0,15 mg/kg. The anaethesia depth will be monitored by the bispectral index (BIS). Orotracheal intubation will be performed, the patient will be ventilated to controlled volume with 6-8 mL/kg of current volume based on expected body weight (PBW). The respiratory rate will be adjusted to have an ETCO2 between 35 and 45 mmHg. The anesthesia will be maintained through the Sevorane at 0.7-1 MAC, the average blood pressure will be controlled through a pressure cuff with a target between 60 and 80 mmHg. The Fio2 will be adapted to obtain saturation \> 94% with 5 cmH2O PEEP.
Treatment: TAVR
- Local AnesthesiaExisting treatment, for comparison
Local anesthesia at the device introduction site will be obtained by infiltration of Naropein.
Treatment: TAVR
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Sedation or General Anesthesia During Trancatheter Aortic Valve Implantation Procedure : ANESTAVI Study
- Record updated
- 30 September 2025