Silent and Apparent Neurological Injury in Transcatheter Aortic Valve Implantation (TAVI)

Not Applicable

Recruiting

• Conditions: Transcatheter Aortic Valve Implantation (TAVI); Neurological Injury; Cardiovascular - Other cardiovascular diseases; Surgery - Other surgery; Stroke - Ischaemic

• Registration Number: ACTRN12613000083796
• Lead Sponsor: Critical Care Research Group (CCRG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

All consenting patients undergoing transcatheter aortic valve implantation (TAVI) via the transfemoral, transaortic and transapical routes with the Edwards SAPIEN-XT valve under general anaesthetic.

Exclusion Criteria

1. Lacks capacity to consent for him or herself.
2. Pre-existing neurological impairment measured as modified Rankin Score >=3.
3. Contraindication to MRI (including incompatible metallic prosthesis/foreign body, inability to lie flat, claustrophobia requiring sedation)
4. Non or poor English-speaking due to nature of cognitive testing and unknown validity in such populations
5. Previous aortic valve repair/replacement.
6. Coronary artery disease requiring revascularisation (including patients undergoing combined AVR and CABG).

Study & Design

• Study Type: Observational
• Study Design: Not specified