NCT06121921

RESTORE-TAVI Pilot

A Pilot Study Assessing the Feasibility and Effectiveness of a Perioperative Multi-component Intervention in Patients With Acute Decompensated Aortic Stenosis Undergoing Urgent Transcatheter Aortic Valve Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Barts & The London NHS Trust · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot randomised control study assessing the feasibility and effectiveness of a perioperative multi-component intervention aimed at reducing adverse hospital events and improving functional outcomes in patients with acute decompensated aortic stenosis undergoing urgent transcatheter aortic valve implantation compared to standard care. The intervention will consist of physical rehabilitation, delirium prevention, nutritional supplementation and anaemia correction (where indicated). The primary objective is to determine the feasibility and safety of delivering this intervention Secondary objectives include investigating the impact on adverse hospital events such as hospital-acquired disability and post-TAVI delirium, and on health-related quality of life and functional recovery following TAVI.

Conditions

• Frailty
• Aortic Stenosis

Interventions

Type	Name	Description
OTHER	Perioperative multi-component intervention	Physical Component Self-directed daily non-ambulatory exercise programme, comprising: * Rubber ball squeezes (3 sets of 12 reps, per hand) * Bicep curls (3 sets of 12 reps) * Leg extensions (3 sets of 12 reps) * Chair rises (3 sets of 12 reps) * Arm stretches (3 sets of 3 reps) Additional encouragement to mobilise Cognitive Component: Delirium prevention strategies including orientation, hydration, bowel/bladder function, infection control, analgesia, polypharmacy and cognitive stimulation Nutritional Component: * Formal dietician review if MUST score ≥ 2 * IV ferritin if LVEF \<45% and serum ferritin \<100ng/mL or ferritin 100-299ng/mL with TSAT \<20%

Timeline

• Start date: 2024-06-07
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2023-11-08
• Last updated: 2025-05-23

Locations

1 site across 1 country: United Kingdom