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Completed

NCT Number: NCT06121921

RESTORE-TAVI Pilot

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barts and the London NHS Trust

London, EC1A 7BE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 70 years
  • Ability to provide written informed consent
  • Ability to speak English

Exclusion criteria

  • Clinical instability defined as requiring use of inotropes/mechanical-circulatory support during admission or post-cardiac arrest
  • Active delirium (4AT score ≥ 4) at time of recruitment
  • Parkinson's disease (Hoehn & Yahr stage 3-5)
  • Recent stroke (within 7 days preceding recruitment)
  • Terminal condition (e.g. metastatic cancer) with life expectancy < 12 months
  • Clinical unsuitable for recruitment to trial according to the discretion of the research team

Treatment and study plan

Perioperative multi-component intervention

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%

Primary outcomes

  1. Feasibility: Recruitment rates

    Time frame: 1 year

    Average number of patients per month willing to give informed consent and be randomised into a trial of a perioperative frailty intervention

  2. Feasibility: Safety

    Time frame: On discharge: e.g. 2-7 days

    In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality

Secondary outcomes

  1. Incidence of hospital-acquired disability

    Time frame: 30 days

    defined as loss of ≥ 1 ADL at discharge compared to admission; and followed-up at 30 days after discharge

  2. Incidence of delirium

    Time frame: Daily (during inpatient admission) until the seventh day post-TAVI and then twice weekly thereafter

    Assessed daily during hospitalisation by using 4AT until the seventh day post-TAVI and then twice weekly thereafter

  3. Changes in health-related quality of life

    Time frame: 30 days

    Measured using EQ-5D-5L at baseline and 30 days post discharge via telephone

  4. Changes in physical frailty

    Time frame: 30 days

    By comparing SARC-F (strength, assistance with walking, rise form a chair, climb stairs and falls) questionnaire at baseline and 30 days (via telephone) after discharge

  5. Changes in physical frailty

    Time frame: On discharge: e.g. 2-7 days

    By comparing dominant handgrip strength at admission and discharge - average of 3 trials of maximal isometric grip measured in kilograms using a Jamar hydraulic hand dynamometer (Anatomy Supply Partners LLC, Georgia, USA).

  6. Changes in physical frailty

    Time frame: On discharge: e.g. 2-7 days

    By comparing timed chair rises at admission and discharge - time (measures in seconds) to complete five chair rises without using arms.

  7. Change in cognitive function

    Time frame: 30 days

    Assessed using T-MoCA at admission and 30 days post discharge via telephone

  8. Change in mood

    Time frame: 30 days

    Assessed using HADS at admission and 30 days post discharge via telephone

  9. Incidence of falls during hospitalisation

    Time frame: On discharge: e.g. 2-7 days

  10. Length of hospital stay

    Time frame: On discharge: e.g. 2-7 days

    Duration of inpatient stay at tertiary centre

  11. Discharge destination

    Time frame: On discharge: e.g. 2-7 days

    e.g. to patient's own home, long-term care facility or district general hospital

  12. Unplanned readmissions

    Time frame: 30 days

    Measured at 30 days post discharge from tertiary centre using hospital records and patient telephone-interview

  13. Mortality

    Time frame: 30 days

    Measured at 30 days post discharge using hospital records and NHS Spine database

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • Imperial College London

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2023
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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