RESTORE-TAVI Pilot

Barts & The London NHS Trust

Status: Begins enrollment in 3 months

Conditions: Frailty; Aortic Stenosis

Treatments: Other: Perioperative multi-component intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06121921

330818

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Intervention

Experimental group

Description:

Perioperative multi-component intervention

Treatment:

Other: Perioperative multi-component intervention

Control

No Intervention group

Description:

Routine inpatient care