The Neuro-PROTECT Trial: Efficacy of two neuroprotection strategies for decreasing the incidence of neurological injury in patients undergoing Transcatheter aortic valve implantation (TAVI)

Not Applicable

• Conditions: Aortic Stenosis; Transcatheter Aortic Valve Implantation (TAVI); Perioperative Stroke; Neurological - Other neurological disorders; Anaesthesiology - Other anaesthesiology; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12616000562471
• Lead Sponsor: The Prince Charles Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) Informed consent for participation; 2) severe aortic stenosis requiring management with isolated TAVI with an Edwards SAPIEN-XT prosthesis under general anaesthetic, as determined by the local 'heart team'; 3) Pre-procedural mini-mental state examination score greater than or equal to 24; 4) stable haemoglobin.

Exclusion Criteria

1) <65 years of age; 2) pre-existing neurological impairment including previous clinical cerebrovascular event or cognitive dysfunction; 3) contraindication to MRI (including incompatible prostheses / foreign body, inability to lie flat, claustrophobic requiring sedation); 4) contraindication to proposed neuroprotective intervention (e.g., previous thromboembolic disease, peripheral vascular disease etc.); 5) non- or poor english speaking (due to the unknown validity of neuropsychiatric battery in such a population); 6) chronic kidney or liver disease; 7) Patients with diabetes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified