Aortic valve stenosis stenosis of the aortic valve
Conditions
Interventions
Coronary hemodynamic
TAVI
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Patients with severe (senile) aortic stenosis (AVA 40mm and maximum jet velocity >4 m/s or or aortic valve area index =1 coronary stenosis >50%) - Patient understands the study requirements and the treatment procedures, and provides written informed consent. - Patient agrees and is capable of returning to the study hospital for all required scheduled follow up visits
Exclusion criteria
Exclusion criteria: - Patient is able to give informed consent - Absence of coronary artery disease (defined as >=1 coronary stenosis >50% as depicted on coronary arteriogram during TAVI-screening) - Subjects with an acute STEMI within 30 days preceding the index procedure (TAVI). - Significant left main - Inability to get per procedural reliable, intracoronary measurements (due to place of lesion, unreliable signals, mechanical defects etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Invasive intracoronary measurements (FFR, CFR, MR, iFR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints: - Standard follow-up criteria (physical examination, ECG, standard laboratory tests) - Valve function and left ventricular function parameters and volumes (as measured with cardiac ultrasonography and cardiac CT) - Cardiac symptoms (dyspnea (New York Heart Association/ NYHA classification), angina pectoris (Canadian Cardiologist Society/ CCS score)) - Quality of life (QoL) | — |
Countries
The Netherlands
Outcome results
None listed