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

The PURE TAVI trial is studying a medical procedure called Transcatheter Aortic Valve Implantation (TAVI), which is used to treat patients with severe aortic stenosis, a condition where the heart's aortic valve becomes narrowed and restricts blood flow. This trial aims to find out if performing TAVI without a common preliminary test called coronary angiography (which checks for blockages in the heart's blood vessels) is just as safe and effective as the traditional approach that includes this test. The hope is that skipping coronary angiography may reduce risks for older patients or those with other health issues who are at higher risk for complications.

To participate in this trial, you must be over 18 and diagnosed with severe aortic stenosis, and your heart team should believe you are a suitable candidate for TAVI. You should also be willing to provide consent and attend follow-up visits. The trial will include around 620 patients across 20 centers in Europe, and participants can expect to be followed for about two years after the procedure. If you meet the eligibility criteria, this study could help improve TAVI procedures for patients in the future.

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.