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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Simon
Redwood
simon.redwood@gstt.nhs.uk
Vitaliy
Androshchuk
Vitaliy.androshchuk@gstt.nhs.uk
Other forms of heart disease
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Aortic stenosis (AS), is a condition in which the aortic valve becomes narrowed as people get older, causing the heart pump (the left ventricle) to struggle to push blood through it, leading to breathlessness, chest pain and blackouts. If left untreated, the prognosis is bleak (similar to lung cancer). Previously the only effective treatment for AS was a valve replacement via open heart surgery, which was too high risk for many patients to undergo, meaning they were left without treatment. Over the last decade transcatheter aortic valve implantation (TAVI) has emerged as a treatment option for most patients with severe symptomatic AS. In TAVI, a new valve is inserted through a small tube, usually in the leg artery, which avoids open heart surgery.
Clinical outcomes after TAVI have significantly improved with the accumulation of operator and institution experience as well as the wide use of newer generation devices. However, a significant minority of patients undergoing TAVI derive little or no benefit from the procedure. Nearly a third describe no improvement in quality of life, or die within the first year. To combat this problem, it is essential we develop more sophisticated means of predicting adverse outcomes related to TAVI, to improve the selection of patients and identify patients where the potential benefit of the procedure is outweighed by unfavourable outcomes.
TAVI-related complications, of which vascular complications are amongst the most common, can critically influence TAVI outcomes. These are associated with increased costs, longer hospitalisation, greater morbidity and mortality. Current means of predicting complications after TAVI are limited.
Assessment of physical recovery and improvement of symptoms and quality of life after TAVI is an important aspect of examining the outcomes of treatment. This is often a more meaningful and relevant treatment goal in the TAVI cohort than ‘hard’ clinical outcomes (like death and stroke) alone. Traditionally, less emphasis has been put on the assessment of the right side of the heart (the right ventricle) in evaluating physical recovery after TAVI.
We propose:
1. A retrospective study to create a tool for predicting the risk of clinical outcomes related to vascular complications in patients treated with TAVI.
2. A prospective study to evaluate the significance of the right side of the heart on the clinical outcomes related to functional recovery in patients undergoing TAVI.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
Retrospective Study: Valve-in-valve TAVI, multiple combined percutaneous interventions in addition to TAVI, existing mitral prosthesis/MitraClip/Pascal), non-transfemoral approach, complex valvular access requiring assistance from vascular surgeon as provisional strategy. Prospective Study: Extracardiac limitations of ambulatory exercise, cardiac rehab opt out, non-transfemoral TAVI, haemodynamic instability/cardiogenic shock, LVEF < 40%, poorly controlled AF, severe COPD, primary pulmonary hypertension, evidence of cardiac amyloid, more than moderate concomitant valvular heart disease other than aortic stenosis, previous sternotomy, permanent pacemaker implant, patients enrolled in another study where participation would involve deviation from either protocol.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by King's College London and funded by BRITISH HEART FOUNDATION .
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Read full details
for Trial ID: CPMS 55857
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