I35.0
Conditions
Interventions
Group 1: Computed tomography-centered evaluation prior to transcatheter aortic valve implantation including coronary artery assessment and referral for invasive coronary angiography only in case of su
Sponsors
Koordinierungszentrum für Klinische Studien der Philipps - Universität Marburg (Standort Gießen)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Symptomatic severe stenosis of the native aortic valve (aortic valve opening area =1,0cm2 and/or mean pressure gradient =40mmHg). Planned diagnostics before TAVI (CT using a single-heartbeat scanner, invasive coronary angiography) at the respective study center. Indication for TAVI (Heart Team consensus according to current guidelines). Willingness to voluntarily participate in the study with a signed consent form.
Exclusion criteria
Exclusion criteria: Known coronary artery disease (e.g., post-PCI; post-CABG). Invasive coronary angiography =6 months before randomization. TAVI via an access route other than transfemoral. Heart failure NYHA stage IV; eGFR <30 ml/min/1.73m². Cognitive and language deficits. Chronic alcohol or drug abuse. Known pregnancy at the time of inclusion. Life expectancy <1 year due to another non-cardiac disease. Participation in a clinical interventional study. Acute COVID-19 infection. Heart rate =100/min. Systolic blood pressure <90 mmHg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of invasive coronary angiographies without significant stenosis (defined as >70% luminal stenosis according to quantitative coronary analysis, or an invasively measured fractional flow reserve 2.50 mm, comparing between the primarily non-invasive group with the control group from baseline until 90 days after TAVI. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) A composite of adverse cardiac events (cardiovascular death, new myocardial infarction, ischemia-driven revascularization, hospitalization for unstable angina or heart failure) at discharge, 3 months and 1 year following transcatheter aortic valve implantation 2) Vascular complications related with invasive coronary angiography and percutaneous coronary intervention at discharge, 3 months and 1 year following transcatheter aortic valve implantation. 3) Cumulative use of contrast material at discharge, 3 months and 1 year following transcatheter aortic valve implantation. 4) Cumulative radiation dose at discharge, 3 months and 1 year following transcatheter aortic valve implantation. 5) Rate of acute kidney injury at discharge, 3 months and 1 year following transcatheter aortic valve implantation. 6) Symptom status and change from baseline in symptom status at discharge, 3 months and 1 year following transcatheter aortic valve implantation. 7) Quality of life and change from baseline in quality of life at discharge, 3 months and 1 year following transcatheter aortic valve implantation. 8) Resource utilization from baseline to discharge, 3 months and 1 year following transcatheter aortic valve implantation applying standard costs (in Euro) 9) Application of computed tomography-based fractional flow reserve (CT-FFR) and its theoretical impact on the primary outcome. | — |
Countries
Germany
Contacts
Public ContactMatthias Renker
Kerckhoff-Klinik GmbH
Outcome results
None listed