Direct Aortic vs Subclavian Access for TAVI: a Review of the Outcomes in the UK

February 24, 2016 updated by: David Hildick-Smith, Royal Sussex County Hospital
A retrospective analysis of outcomes of all patients who received TAVI via the subclavian or direct aortic approach between January 2011 and January 2016

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Nil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MACE
Time Frame: Up to 5 years (average 3 years)
Up to 5 years (average 3 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedural Complications
Time Frame: 30 dyas post procedure
30 dyas post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Sussex County Hospital

Collaborators

National Institute for Cardiovascular Outcomes Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RoyalSussexTAVISCvsDA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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