Treatment of Severe Aortic Stenosis with Transfemoral TAVI with or Without Coronary Angiogram During Diagnostic Work-up (PURE TAVI)

Launched by REDE OPTIMUS HOSPITALAR SA · Mar 20, 2025

Keywords

ClinConnect Summary

This study aims 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 revascularization is included, in patients with significant aortic stenosis who do not experience typical angina pectoris classified as CCS 3 or higher.

Hypothesis: For patients with significant aortic stenosis who do not experience typical angina pectoris classified as CCS 3 or higher, omitting a coronary angiography prior to or during transfemoral TAVI is non-inferior to a traditional diagnostic work-up...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient is older than 18 years with severe AS 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:
• • Patient had a coronary angiogram with or without PCI and/or coronary CT and/or CABG within last 5 years.
• • Left main PCI in the medical history
• • Patient has 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 history
• • Patient has been treated for acute myocardial infarction within 30 days before randomization.
• • Patient has a planned open-heart surgery.
• • 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.
• • Female patient who is pregnant at the time of inclusion.

Trial Officials