Stenoses, AorticANESTAVINCT04347603
Sedation or General Anesthesia During TAVR
A study testing TAVR in people with Stenoses, Aortic, run by University Hospital, Montpellier at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stenoses, Aortic
- What is being tested?
- TAVR
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Dec 2020to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Sedation or General Anesthesia During Trancatheter Aortic Valve Implantation Procedure : ANESTAVI Study
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.
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.
Read the 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 growing experience of intereventional temas with the technique, improvement of device technology, and expansion of the technique to patients with lower surgical risk, the procedure is mostly currently performed under local anaesthesia with or without conscious sedation (TAVR-LA-CS) rather than by the traditional general anaesthesia approach (TAVR-GA).
The purpose of this study is to compare the safety (primary outcome) and efficiency (secondary outcome) of local anesthesia (LA) with conscious sedation (CS) versus general anesthesia (GA) for the TAVR procedure performed with transfemoral access.
This is a blindly randomized, non-inferiority controlled trial. The study will include all consecutive patients referred to the Cardiology Department of the CHU of Montpellier, France, for TAVR by transfemoral access which is the default strategy. Procedure is indicated for severe symptomatic aortic valve stenosis with high or intermediate surgical risk or with contraindication to surgery and after decision of the multidisciplinary team according to the current recommendations of the European society of cardiology. Patients are randomized into two groups with surgical risk stratification : one with general anesthesia (experimental group) and one with local anesthesia with sedation: (control group) in a 1/1 ratio. Exclusion criteria include contraindication to GA or LA-CS based on hemodynamic status or comorbidities. The primary composite endpoint combines the major peri and post-operative adverse events (72 hours), including hemodynamic instability and major complications (VARC 3 criteria). Secondary criteria include length of intensive care unit (ICU) hospitalization and total hospital stay, duration of intervention, analgesic dose up to 72 hours, finger oximetry results, transition to GA in the AL group, fluoroscopic time, patient and operator satisfaction (questionnaires for patients, interventional cardiologists and anesthesiologists) and mortality at 30 day follow-up.
It is expected that 20% of patients will have an event defined by the main judgement outcome. To balance the various expected benefits of LA-CS over the length of stay, duration in ICUC and opioid drug use, the non-inferiority threshold was set at an absolute difference of up to 15%, or 35% of event rates in the experimental arm.
Based on this threshold and the above assumptions, and using 80% power and 5% Type I error (for a one-sided test), 109 patients are must be included in each arm, for a total of 218 patients with a randomization rate of 1:1.
The inclusion period will be 24 months or as soon as the required number of subjects is reached. Follow-up includes a medical assessment during the peri-operative period (72h) and at the end of the hospital stay and a clinical evaluation by phone survey at 30 days.
- Conditions
- Stenoses, Aortic
- Being tested
- TAVR
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVRProcedure or surgery
Femoral percutaneous aortic prosthesis (TAVR)
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Experimental | - 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. Receives: Procedure: TAVR |
| Local Anesthesia | Active comparator | Local anesthesia at the device introduction site will be obtained by infiltration of Naropein. Receives: Procedure: TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic instability
Hemodynamic instability (defined by the need for fluid loading >1500 ml associated or not with the use of inotrope support) within the first 72 hours
Measured: within 72 hours after intervention
Major complications (according to VARC 3 criteria)
Major complications (according to VARC 3 criteria) within the first 72 hours :
- death in hospital,
- major vascular events,
- neurological events,
- myocardial infarction,
- aortic regurgitation >2,
- conductive disorders requiring pacemaker implantation,
- acute renal failure (KDIGO criteria),
- pericardial tamponade.
Measured: within 72 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start8 Dec 2020
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenoses, AorticStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347603
- Sponsor's protocol ID
- RECHMPL19_0350
- Other IDs
- UF7825, 2020-A00497-32
- Acronym
- ANESTAVI
- Status last verified
- May 2024
- First submitted
- 12 Apr 2020
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation or General Anesthesia During Trancatheter Aortic Valve Implantation Procedure : ANESTAVI Study
- ClinicalTrials.gov ID
- NCT04347603
- Acronym / sponsor ID
- ANESTAVI / RECHMPL19_0350
- Conditions
- Stenoses, Aortic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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 growing experience of intereventional temas with the technique, improvement of device technology, and expansion of the technique to patients with lower surgical risk, the procedure is mostly currently performed under local anaesthesia with or without conscious sedation (TAVR-LA-CS) rather than by the traditional general anaesthesia approach (TAVR-GA).
The purpose of this study is to compare the safety (primary outcome) and efficiency (secondary outcome) of local anesthesia (LA) with conscious sedation (CS) versus general anesthesia (GA) for the TAVR procedure performed with transfemoral access.
This is a blindly randomized, non-inferiority controlled trial. The study will include all consecutive patients referred to the Cardiology Department of the CHU of Montpellier, France, for TAVR by transfemoral access which is the default strategy. Procedure is indicated for severe symptomatic aortic valve stenosis with high or intermediate surgical risk or with contraindication to surgery and after decision of the multidisciplinary team according to the current recommendations of the European society of cardiology. Patients are randomized into two groups with surgical risk stratification : one with general anesthesia (experimental group) and one with local anesthesia with sedation: (control group) in a 1/1 ratio. Exclusion criteria include contraindication to GA or LA-CS based on hemodynamic status or comorbidities. The primary composite endpoint combines the major peri and post-operative adverse events (72 hours), including hemodynamic instability and major complications (VARC 3 criteria). Secondary criteria include length of intensive care unit (ICU) hospitalization and total hospital stay, duration of intervention, analgesic dose up to 72 hours, finger oximetry results, transition to GA in the AL group, fluoroscopic time, patient and operator satisfaction (questionnaires for patients, interventional cardiologists and anesthesiologists) and mortality at 30 day follow-up.
It is expected that 20% of patients will have an event defined by the main judgement outcome. To balance the various expected benefits of LA-CS over the length of stay, duration in ICUC and opioid drug use, the non-inferiority threshold was set at an absolute difference of up to 15%, or 35% of event rates in the experimental arm.
Based on this threshold and the above assumptions, and using 80% power and 5% Type I error (for a one-sided test), 109 patients are must be included in each arm, for a total of 218 patients with a randomization rate of 1:1.
The inclusion period will be 24 months or as soon as the required number of subjects is reached. Follow-up includes a medical assessment during the peri-operative period (72h) and at the end of the hospital stay and a clinical evaluation by phone survey at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Experimental | Procedure: TAVR- 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. |
| Local Anesthesia | Active comparator | Procedure: TAVRLocal anesthesia at the device introduction site will be obtained by infiltration of Naropein. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Chronic respiratory insufficiency treated by long term oxygeno therapy
- Pulmonary hypertension above 50mmHg
- BMI>35
- TAVI by carotidian or apical way
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVRFemoral percutaneous aortic prosthesis (TAVR) | Procedure or surgery | General Anesthesia, Local Anesthesia |
Primary outcome
Hemodynamic instability
Time frame: within 72 hours after intervention
Hemodynamic instability (defined by the need for fluid loading >1500 ml associated or not with the use of inotrope support) within the first 72 hours
Major complications (according to VARC 3 criteria)
Time frame: within 72 hours after intervention
Major complications (according to VARC 3 criteria) within the first 72 hours : * death in hospital, * major vascular events, * neurological events, * myocardial infarction, * aortic regurgitation >2, * conductive disorders requiring pacemaker implantation, * acute renal failure (KDIGO criteria), * pericardial tamponade.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR in people with Stenoses, Aortic, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic instability (time frame: within 72 hours after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.