NCT06870734

Brief 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. We aim to compare the locoregional approach to gerneral anesthesia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 7, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2026

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

March 6, 2025

Last Update Submit

March 6, 2025

Conditions

Aortic Stenosis

Keywords

general anesthesiacervical blocklocoregional anesthesiaTAVRcardiovascvular intervention

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint

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

    7 days

Secondary Outcomes (5)

  • Death

    7 days

  • Stroke

    7 days

  • 30 day mortality

    30 days

  • 1 year mortality

    1 year

  • Vasopressive drugs

    1 day

Other Outcomes (1)

  • Pacemaker implantation

    7 to 30 days

Study Arms (2)

General anesthesia

Patients undergoing transcarotid transaortic valve replacement under general anesthesia

Regional anesthesia

Patients undergoing transcarotid transaortic valve replacement under regional anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

Richard DESCAMPS, MD

CONTACT

descamps-r@chu-caen.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 11, 2025

Study Start

March 7, 2025

Primary Completion

December 31, 2025

Study Completion

March 6, 2026

Last Updated

March 11, 2025

Record last verified: 2025-03