Severe aortic stenosis Severe narrowing of the left heart valve
Conditions
Interventions
The aim of the study is to evaluate whether a TAVI pathway without prior coronary angiography is non-inferior to a conventional TAVI pathway, in which routine coronary angiography with or without reva
Sponsors
Rede Optimus Hospitalar AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient is older than 18 years with severe aortic stenosis considered for TAVI by a multidisciplinary heart team.Patient is candidate for transfemoral TAVI as per local standards and current guidelines.Patient is willing and capable to give written consent to participate to the trial and confirmed to be able to attend the expected follow up visits.
Exclusion criteria
Exclusion criteria: Patient had a coronary angiogram with or without percutaneous coronary intervention and/or coronary artery bypass graft or coronary computed tomography angiography within last 5 years.Left main Percutaneous coronary intervention in the medical historyPatient has angina CCS of 3 or more.Patient has left ventricular ejection fraction <30%.Patients in whom TAVI through femoral access is ad priori not possible based on clinical assessment or medical historyPatient has been treated for acute myocardial infarction within 30 days before randomization.Patient has a planned open-heart surgery.Female patient who is pregnant at the time of inclusion and female patient of childbearing potential.Patient has a life expectancy less than 1 year due to other severe non-cardiac disease.Patient is participating in another clinical study with an investigational product that has not yet completed the follow up period.Patient has received previous treatment for aortic valve implantation or replacement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint:Composite of all-cause death, spontaneous or periprocedural myocardial infarction, urgent revascularization during unplanned hospitalization, readmission for heart failure, acute renal injury, major or life-threatening or disabling bleeding, major vascular complication, or any stroke at 12-months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite of all-cause death, spontaneous or periprocedural myocardial infarction, urgent revascularization during unplanned hospitalization, readmission for heart failure, acute renal injury, major or life-threatening or disabling bleeding, major vascular complication, or stroke at 24-months follow-upIndividual components of the primary endpoint at 6-months follow-upChange in angina class by CCS angina between baseline and 6 months follow-up.Change in New York Heart Association functional class (I, II, III, or IV) between baseline and 6 months follow-up.EQ-5D-5L change between baseline and 6 months follow-up.Kansas City Cardiomyopathy Questionnaire (KCCQ) change between baseline and 6 months follow-up.Any revascularization at 12-months follow-upIndividual components of the primary endpoint at 12-months follow-up.Change in angina class by CCS angina between baseline and 12 months follow-up.Change in New York Heart Association functional class (I, II, III, or IV) between baseline and 12 months follow-up.EQ-5D-5L change between baseline and 12 months follow-up.KCCQ change between baseline and 12 months follow-upIndividual components of the primary endpoint at 24-months follow-up.Any revascularization at 24-months follow-upChange in angina class by CCS angina between baseline and 24 months follow-up.Change in New York Heart Association functional class (I, II, III, or IV) between baseline and 24 months follow-up.EQ-5D-5L change between baseline and 24 months follow-up.KCCQ change between baseline and 24 months follow-up | — |
Countries
Austria, Czech Republic, France, Germany, Italy, Netherlands, Switzerland
Contacts
Public ContactGV Vaz
Rede Optimus Hospitalar AG
Outcome results
None listed