Novel Parameters for the Assessment of LFLG AS Peri-TAVI Procedure
Research type
Research Study
Full title
Utility of Novel Echocardiographic and Invasive Haemodynamic Measurements in the assessment of patients with Low Flow Low Gradient Aortic Stenosis undergoing TAVI; A pilot study.
IRAS ID
303172
Contact name
James Cotton
Contact email
Sponsor organisation
The Royal Wolverhampton NHS Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Trans-Catheter Aortic Valve implantation (TAVI) is an established therapy for the treatment of patients with symptomatic narrowing of the aortic valve (Aortic Stenosis). It involves the implantation of a new valve via a tube inserted into an artery at the top of the leg, removing the need for surgical opening of the chest. It is associated with a reduction in symptoms and improved survival in selected patients.
Patients with reduced heart function prior to TAVI represent a difficult group to treat. These patients are at higher procedural risk compared to those with good heart pump function. In some, treatment leads to complications and/or little or no improvement in symptoms or heart pump function.
It is important that we try to predict the outcome of TAVI in this high-risk population for clinical and health economic reasons.
The current technique for assessing the likelihood of improvement of heart pump function following TAVI (contractile reserve on stress echocardiography) has been shown not to predict outcome well.
This pilot study of ten patients will involve the assessment of a variety of novel markers of heart strength (contractility) at the time of the TAVI, to see whether any predict how well patients with weak hearts will respond.
At their routine stress echocardiogram (cardiac ultrasound) prior to the TAVI, participants will have some additional markers of muscle strength measured.
During the TAVI procedure, additional measurements relating to cardiac contractility will be taken using a drug to speed up the the heart(dobutamine) and a pressure wire. Echocardiograms will be undertaken following TAVI and at 3 months to assess the outcome of the procedure.This pilot study will be used to inform the feasibility of a larger, multi-centre trial powered to assess the value of the measured novel techniques to yield prognostic information regarding outcomes in this patient cohort.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
22/SW/0012
Date of REC Opinion
24 Jan 2022
REC opinion
Favourable Opinion