Implantable Sensor in Severe Aortic Stenosis (ISAS study) Version 1.0
Research type
Research Study
Full title
The use of activity and impedance from a continuous, implantable sensor to detect deterioration in asymptomatic patients with severe aortic stenosis under a watchful waiting program (ISAS study).
IRAS ID
208215
Contact name
Guy WL Lloyd
Contact email
Sponsor organisation
Barts Health NHS Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Aortic stenosis (narrowing of the valve) is the commonest form of heart valve disease with the main symptoms being breathlessness, chest pain or loss of consciousness. The conventional indications for aortic valve replacement are in the presence of symptoms of if cardiac function is impaired as a consequence of the narrowed valve. A further indication for surgery is if the patient exhibits symptoms during exercise. The close proximity of the aortic valve to the conducting system of the heart renders some patients with severe aortic stenosis to heart rhythm disturbances (cardiac arrhythmias). Some of these patients may not have any symptoms. Implantable cardiac devices automatically collect data on heart rhythm abnormalities (cardiac arrhythmias). They have the advantage that they are more comprehensive and objective than standard monitoring.
This study will use the combination of implantable loop recorder monitoring and exercise testing to identify a subset of patients with severe aortic stenosis, without a conventional indication for valve replacement, who may benefit from early intervention or closer follow up.
REC name
London - Stanmore Research Ethics Committee
REC reference
17/LO/0929
Date of REC Opinion
20 Jun 2017
REC opinion
Further Information Favourable Opinion