General Anesthesia Versus Loco-Regional Anesthesia for Tr... | NCT06870734

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

NCT06870734

Sponsor

University Hospital, Caen

Status

Not yet recruiting

Last Update Posted

Mar 11, 2025Actual

Enrollment

44Estimated

Phase

Not provided

Conditions

Aortic Stenosis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2025Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Mar 6, 2026Estimated

First Submitted Date

Mar 6, 2025

First Submission Date that Met QC Criteria

Mar 6, 2025

First Posted Date

Mar 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2025

Last Update Posted Date

Mar 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
General anesthesia		Patients undergoing transcarotid transaortic valve replacement under general anesthesia
Regional anesthesia		Patients undergoing transcarotid transaortic valve replacement under regional anesthesia

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary endpoint	Composite endpoint combining mortality and stroke in the first post-operative week	7 days

Secondary Outcomes

Measure	Description	Time Frame
Death	Death occuring during the first week after intervention	7 days
Stroke	Stroke occuring during the first week after the intervention

Other Outcomes

Measure	Description	Time Frame
Pacemaker implantation	Pacemaker implantation during the index hospitalisation	7 to 30 days

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Richard DESCAMPS, MD	Contact			descamps-r@chu-caen.fr

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided