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RESTORE-TAVI Pilot

NCT06121921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-23

No results posted yet for this study

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

Interventions

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%

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • Barts & The London NHS Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-07
Primary Completion
2025-05-01
Completion
2025-05-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06121921 on ClinicalTrials.gov