Coronary Artery Disease Assessment Strategies in TAVI Patients

Not Applicable

Not yet recruiting

• Conditions: Transcatheter Aortic Valve Replacement; Coronary Artery Disease; Heart Disease Risk Factors

• Registration Number: NCT06559332
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-14
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion:<br><br>• Severe aortic stenosis defined by aortic valve area (AVA) =1cm2 AND mean gradient<br><br> - 40 mmHg or peak velocity =4.0 m/s<br><br>OR<br><br>if mean gradient <40 mmHg and peak velocity (Vmax) <4 m/s and stroke volume indexed to<br>body surface area (SVi) = 35 mL/m2 and LVEF =50% then if CT-derived aortic valve calcium<br>score >2000 Agatston units in men, >1300 in women<br><br>OR<br><br>if mean gradient <40 mmHg and Vmax <4 m/s and SVi = 35 mL/m2 and LVEF <50% then if<br>CT-derived aortic valve calcification >2000 Agatston units in men, >1300 in women OR if<br>low-dose dobutamine stress echocardiography with flow reserve (>20% increase in stroke<br>volume) and AVA =1cm2<br><br> - Selected for treatment with transfemoral TAVI.<br><br> - Written informed consent.<br><br>Exclusion Criteria:<br><br> - Concomitant valvular heart disease or ascending aortic aneurysm with indication for<br> surgery or intervention<br><br> - Unprotected left main coronary stenosis >50% based on coronary computed tomography<br> angiography derived from routine pre-TAVI CT<br><br> - Left ventricular ejection fraction (LVEF) < 40%<br><br> - New regional wall motion abnormalities on echocardiography<br><br> - Myocardial infarction in previous 6 months<br><br> - Coronary angiography in previous 6 months<br><br> - Prior left main stenting

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of all-cause death, myocardial infarction, any stroke, bleeding , acute kidney injury and heart failure hospitalization;Composite of all-cause death, myocardial infarction, any stroke and heart failure hospitalization

Secondary Outcome Measures

Name	Time	Method
Patient reported health status;Patient reported health status;Patient reported health status;Rate of all cause death;Rate of cardiovascular death;Rate of disabling strokes;Rate of myocardial infarction;Rate of unplanned, urgent revascularization;Rate of elective revascularization;Rate of cardiovascular hospitalization;Rate of heart failure hospitalization;Rate of bleeding;Rate of acute kidney injury;Rate of tachyarrhythmia;Rate of permanent pacemaker implantation