RESTORE-TAVI Pilot

NCT ID: NCT06121921

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-07
• Study Completion Date: 2025-05-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

Perioperative multi-component intervention

Group Type: EXPERIMENTAL

Perioperative multi-component intervention

Intervention Type: OTHER

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%

Control

Routine inpatient care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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%

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age > 70 years

2. Ability to provide written informed consent

3. Ability to speak English

Exclusion Criteria

1. Clinical instability defined as requiring use of inotropes/mechanical-circulatory support during admission or post-cardiac arrest

2. Active delirium (4AT score ≥ 4) at time of recruitment

3. Parkinson's disease (Hoehn & Yahr stage 3-5)

4. Recent stroke (within 7 days preceding recruitment)

5. Terminal condition (e.g. metastatic cancer) with life expectancy < 12 months

6. Clinical unsuitable for recruitment to trial according to the discretion of the research team

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Barts and the London NHS Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

330818

Identifier Type: -

Identifier Source: org_study_id