NCT02695147

Brief Summary

A retrospective analysis of outcomes of all patients who received TAVI via the subclavian or direct aortic approach between January 2011 and January 2016

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
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Status
unknown

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

February 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

February 24, 2016

Last Update Submit

February 24, 2016

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • MACE

    Up to 5 years (average 3 years)

Secondary Outcomes (1)

  • Procedural Complications

    30 dyas post procedure

Study Arms (2)

TAVI via Subclavian approach

Any TAVI procedure using any valve type performed via the subclavian approach

Procedure: TAVI

TAVI via Direct Aortic approach

Any TAVI procedure using any valve type performed via the direct aortic approach

Procedure: TAVI

Interventions

TAVIPROCEDURE
TAVI via Direct Aortic approachTAVI via Subclavian approach

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who received TAVI via the subclavian or direct aortic approach in the UK

You may qualify if:

  • Recieve TAVI via subclavian or direct aortic apporach in the UK

You may not qualify if:

  • Nil

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

Study Design

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

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 1, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

March 1, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share