Aortic StenosisGALATTAVINCT06870734
General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement
An observational study of Aortic Stenosis, run by University Hospital, Caen.
Trial summary
Transcarotid transcatheter aortic valve replacement (Transcarotid TAVR) has been increasingly used as an alternative to the transfemoral approach. The general anesthesia, locoragional anesthesia or local anesthesia are three anesthesia techniques that can be used for transcarotid TAVR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 7 Mar 2025to 6 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent a transcarotid TAVR at the University Hospital of Caen between October 2021 (when the first TAVR was performed under locoregional anesthesia) and December 2024
Who may be able to join
- Adult patients who underwent a transcarotid TAVR at the University Hospital of Caen between October 2021 (when the first TAVR was performed under locoregional anesthesia) and December 2024
Who cannot join
- Patient's refusal to allow data collection and lack of data regarding the primary endpoint
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Richard DESCAMPS, MD contact
About this study
Official title: General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement - a Retrospective Cohort Study
Transcarotid transcatheter aortic valve replacement (Transcarotid TAVR) has been increasingly used as an alternative to the transfemoral approach. The general anesthesia, locoragional anesthesia or local anesthesia are three anesthesia techniques that can be used for transcarotid TAVR. We aim to compare the locoregional approach to gerneral anesthesia.
- Conditions
- Aortic Stenosis
- Keywords
- general anesthesia, cervical block, locoregional anesthesia, TAVR, cardiovascvular intervention
- 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.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Patients undergoing transcarotid transaortic valve replacement under general anesthesia | |
| Regional anesthesia | Patients undergoing transcarotid transaortic valve replacement under regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Composite endpoint combining mortality and stroke in the first post-operative week
Measured: 7 days
Secondary outcomes (5)
Death
Death occuring during the first week after intervention
Measured: 7 days
Stroke
Stroke occuring during the first week after the intervention
Measured: 7 days
30 day mortality
Death occuring during the first month after intervention
Measured: 30 days
1 year mortality
Death occuring during the first year after intervention
Measured: 1 year
Vasopressive drugs
Use of vasopressive drugs during the intervention
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start7 Mar 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion6 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard DESCAMPS, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870734
- Sponsor's protocol ID
- 2024102821344400000170001538
- Acronym
- GALATTAVI
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 11 Mar 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement - a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06870734
- Acronym / sponsor ID
- GALATTAVI / 2024102821344400000170001538
- Conditions
- Aortic Stenosis
- Keywords
- general anesthesia, cervical block, locoregional anesthesia, TAVR, cardiovascvular intervention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 7 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 6 Mar 2026 (estimated)
- First posted
- 11 Mar 2025 (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.
Transcarotid transcatheter aortic valve replacement (Transcarotid TAVR) has been increasingly used as an alternative to the transfemoral approach. The general anesthesia, locoragional anesthesia or local anesthesia are three anesthesia techniques that can be used for transcarotid TAVR. We aim to compare the locoregional approach to gerneral anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | – | –Patients undergoing transcarotid transaortic valve replacement under general anesthesia |
| Regional anesthesia | – | –Patients undergoing transcarotid transaortic valve replacement under regional anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent a transcarotid TAVR at the University Hospital of Caen between October 2021 (when the first TAVR was performed under locoregional anesthesia) and December 2024
Key inclusion criteria (1 listed)
- Adult patients who underwent a transcarotid TAVR at the University Hospital of Caen between October 2021 (when the first TAVR was performed under locoregional anesthesia) and December 2024
Key exclusion criteria (1 listed)
- Patient's refusal to allow data collection and lack of data regarding the primary endpoint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary endpoint
Time frame: 7 days
Composite endpoint combining mortality and stroke in the first post-operative week
5 secondary outcomes
Death
Time frame: 7 days
Stroke
Time frame: 7 days
30 day mortality
Time frame: 30 days
1 year mortality
Time frame: 1 year
Vasopressive drugs
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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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.
Richard DESCAMPS, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by University Hospital, Caen.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard DESCAMPS, MD (descamps-r@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: 7 days). 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 11 Mar 2025.