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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis; Frailty
• Intervention / Treatment: Other: Perioperative multi-component intervention

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Barts and the London NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Perioperative multi-component intervention	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%
No Intervention: Control; Routine inpatient care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Recruitment rates	Average number of patients per month willing to give informed consent and be randomised into a trial of a perioperative frailty intervention	1 year
Feasibility: Safety	In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality	On discharge: e.g. 2-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hospital-acquired disability	defined as loss of ≥ 1 ADL at discharge compared to admission; and followed-up at 30 days after discharge	30 days
Incidence of delirium	Assessed daily during hospitalisation by using 4AT until the seventh day post-TAVI and then twice weekly thereafter	Daily (during inpatient admission) until the seventh day post-TAVI and then twice weekly thereafter
Changes in health-related quality of life	Measured using EQ-5D-5L at baseline and 30 days post discharge via telephone	30 days
Changes in physical frailty	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	30 days
Changes in physical frailty	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).	On discharge: e.g. 2-7 days
Changes in physical frailty	By comparing timed chair rises at admission and discharge - time (measures in seconds) to complete five chair rises without using arms.	On discharge: e.g. 2-7 days
Change in cognitive function	Assessed using T-MoCA at admission and 30 days post discharge via telephone	30 days
Change in mood	Assessed using HADS at admission and 30 days post discharge via telephone	30 days
Incidence of falls during hospitalisation		On discharge: e.g. 2-7 days
Length of hospital stay	Duration of inpatient stay at tertiary centre	On discharge: e.g. 2-7 days
Discharge destination	e.g. to patient's own home, long-term care facility or district general hospital	On discharge: e.g. 2-7 days
Unplanned readmissions	Measured at 30 days post discharge from tertiary centre using hospital records and patient telephone-interview	30 days
Mortality	Measured at 30 days post discharge using hospital records and NHS Spine database	30 days

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Collaborators: Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Frailty; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 330818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No