NOTION-3
Research type
Research Study
Full title
Routine revascularisation with percutaneous coronary intervention in patients with coronary artery disease undergoing transcatheter aortic valve implantation – the third Nordic Aortic Valve Intervention Trial – NOTION-3
IRAS ID
271450
Contact name
Rajesh Kharbanda
Contact email
Sponsor organisation
Rigshospitalet, Copenhagen
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 0 days
Research summary
Patients having a minimally invasive aortic valve replacement procedure for aortic stenosis (transcutaneous aortic valve implant - TAVI) may also have coronary artery disease (CAD). Up to 50% of TAVI patients also have CAD and this is associated with worse outcomes. Patients having a TAVI have a routine coronary angiogram to check for narrowings before implanting the valve. The severity of the narrowings is checked by measuring the blood pressure on either side. Cardiologists don’t know currently whether it is better to treat severe narrowings with stents or manage them conservatively (no treatment or tablets only) in TAVI patients.
Patients undergoing TAVI for aortic stenosis who are over 18, have symptoms of breathlessness/angina or reduced cardiac function, and who have at least one severe coronary artery narrowing. Patients who have had a heart attack in the past 14 days, more than one coronary artery which is completely closed, or who have disease in the main artery supplying blood to the heart (left main) will be excluded.
The study will be conducted in centres with expertise in carrying out TAVI as a routine procedure.
Patients who are eligible will be approached by the clinical team and referred to the research team. Informed consent will be obtained before any study procedures are carried out. Patients who do not have severe coronary artery narrowings on angiogram will be followed up in a registry. Those with severe narrowings will be randomised 1:1 to receive stents or conservative management.
The TAVI procedure will go ahead as usual.
Patients will be followed up for the study annually at their clinical appointments for 5 years.
The study will measure whether one arm has a higher incidence of death, heart attack or other complications than the other.REC name
South Central - Oxford C Research Ethics Committee
REC reference
20/SC/0340
Date of REC Opinion
4 Jan 2021
REC opinion
Further Information Favourable Opinion