Evaluation of coronary blood flow in patients with severe aortic stenosis treated with transcatheter aortic valve replacement

Evaluation of coronary flow reserve in patients with severe aortic stenosis treated with transcatheter aortic valve replacement

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12618000403235

Acronym

COAST study

Enrollment

Registered

2018-03-20

Start date

2018-03-30

Completion date

Unknown

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aortic stenosis is the commonest valve pathology requiring medical intervention. Aortic stenosis causes restriction and alterations in blood flow to the rest of the body including the coronary arteries which can cause symptoms of fatigue, breathlessness, chest pain and dizziness. Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure where a new valve is inserted inside the old narrowed valve using a balloon catheter. This can relieve the symptoms as blood can once again be pumped freely to the rest of the body without the additional effort. Existing data suggests that this procedure allows partial restoration of normal blood flow to the coronary arteries. However, it remains unclear what the longer term effects of this procedure are. This an important consideration as it will enable us to have a better understanding of this treatment. We aim to conduct assessment in 30 patients undergoing TAVR using cardiac CT, echocardiography and coronary flow measurements around the index procedure and at 6-9 months follow up. We expect to see that there is further restoration of normal coronary physiology at follow up after TAVR.

Interventions

Patients with severe aortic stenosis who are referred for transcatheter aortic valve replacement (TAVR) will have baseline CT coronary angiography (with CT FFR). At the time of TAVR, they will undergo invasive coronary physiological measurements (including pressure and flow) at baseline and hyperaemia, immediately before and after valve deployment. At 6-9 months follow up, they will have repeat CT coronary angiography (with CT FFR) and invasive coronary physiological measurements. Coronary flow

Eligibility

Sex/Gender

All

Age

18 Years to 84 Years

Healthy volunteers

Inclusion criteria

1) Patients with severe aortic stenosis requiring transcatheter aortic valve implantation 2) age greater than or equal to 18 years and less than or equal to 84 years 3) able to provide informed consent

Exclusion criteria

1) patients with significant coronary artery stenosis mandating clinically indicated revascularisation 2) previous myocardial infarction 3) previous ischaemic or haemorrhagic stroke 4) chronic renal impairment, as defined by estimated glomerular filtration rate of less than or equal to 45ml/min/1.73m2 5) previous coronary artery bypass surgery 6) left ventricular ejection fraction <50% or known regional wall motion abnormality on echocardiography 7) atrial fibrillation 8) uncontrolled hypertension, as defined by a pre-procedural blood pressure of >150/90mmHg 9) pharmacologically-treated diabetes mellitus 10) decompensated heart failure 11) severe asthma or resting bradycardia precluding use of adenosine 12) unfavourable coronary anatomy that would prohibit safe guidewire passage 13) women of childbearing age.

Outcome results