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NCT02695147 Clinical Trial

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

Aortic Stenosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02695147
Other study ID # RoyalSussexTAVISCvsDA
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 24, 2016
Last updated February 24, 2016
Start date February 2016
Est. completion date June 2016

Study information
Verified date February 2016
Source Royal Sussex County Hospital
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• TAVI

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Royal Sussex County Hospital National Institute for Cardiovascular Outcomes Research

Outcome
Type Measure Description Time frame Safety issue
Primary MACE Up to 5 years (average 3 years) No
Secondary Procedural Complications 30 dyas post procedure No
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