RESTORE-TAVI Pilot

B

Barts & The London NHS Trust

Status

Not yet enrolling

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)

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

Trial contacts and locations

0

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Central trial contact

Max Sayers

Data sourced from clinicaltrials.gov

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