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NCT Number: NCT06870734

General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patient's refusal to allow data collection and lack of data regarding the primary endpoint

Treatment and study plan

Primary outcomes

  1. Primary endpoint

    Time frame: 7 days

    Composite endpoint combining mortality and stroke in the first post-operative week

Secondary outcomes

  1. Death

    Time frame: 7 days

    Death occuring during the first week after intervention

  2. Stroke

    Time frame: 7 days

    Stroke occuring during the first week after the intervention

  3. 30 day mortality

    Time frame: 30 days

    Death occuring during the first month after intervention

  4. 1 year mortality

    Time frame: 1 year

    Death occuring during the first year after intervention

  5. Vasopressive drugs

    Time frame: 1 day

    Use of vasopressive drugs during the intervention

Other outcomes

  1. Pacemaker implantation

    Time frame: 7 to 30 days

    Pacemaker implantation during the index hospitalisation

Study contacts

Contact information is provided by the study sponsor or research team.

Richard DESCAMPS, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement - a Retrospective Cohort Study

Acronym: GALATTAVI

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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