NCT04906837

Brief Summary

Conduction disturbances are a major complication of TAVI. There is no predictor of post-TAVI conduction disorder. The study of the membranous septum on the pre-TAVI scanner and the valve implantation height are promising and little studied data on the occurrence of post-TAVI conduction disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 20, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

May 25, 2021

Last Update Submit

May 25, 2021

Conditions

Conduction DisturbanceTrans Aortic Valve Implantation (TAVI)

Keywords

membranous septumvalve implantation heightpredictive factors

Outcome Measures

Primary Outcomes (1)

  • One late high-grade AVB

    Presence of at least one late high-grade AVB episode

    between day 7 to one year

Secondary Outcomes (2)

  • CT and angiographic measurements,

    one year

  • intra and inter observer variability

    one year

Interventions

Trans aortic valve implantationDIAGNOSTIC_TEST

Measurement of the membranous septum on the pre TAVI scanner and the valve implantation height

Eligibility Criteria

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

Patients included in the STIM TAVI study with full follow-up (not excluded from STIM TAVI for lack of data)

You may qualify if:

  • years old
  • Patients included in the STIM TAVI study with full follow-up (not excluded from STIM TAVI for lack of data)
  • Patients who did not object to the use of CT and angiography data

You may not qualify if:

  • Oral opposition to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Annecy Genevois

Annecy, 74370, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2021

First Posted

May 28, 2021

Study Start

June 20, 2020

Primary Completion

February 26, 2021

Study Completion

February 26, 2021

Last Updated

May 28, 2021

Record last verified: 2021-05

Locations

FR(1)