Transfemoral TAVI With or Without Coronary Angiogram in Patients With Severe Aortic Stenosis (PURE TAVI)

Summary

This study will be conducted in patients with severe aortic stenosis who are referred for transcatheter aortic valve implantation (TAVI). TAVI is the recommended treatment for severe aortic stenosis. Currently, before undergoing TAVI, most patients undergo a coronary angiography to check whether the coronary arteries are blocked and to assist in appropriate valve sizing. If significant blockages are detected, they are treated before or during TAVI. However, many patients who undergo TAVI are older and often have additional cardiovascular conditions such as hypertension, diabetes, or obesity. These comorbidities increase the risk of complications related to coronary angiography, including kidney injury from contrast dye, bleeding, and vascular complications at the access site. As such, it remains uncertain whether routine coronary angiography is necessary for all patients undergoing TAVI, particularly those without symptoms suggestive of myocardial ischemia. This study aims to determine whether a TAVI treatment pathway without prior coronary angiography is non-inferior to the standard pathway that includes routine coronary angiography, with or without revascularization, in patients with severe aortic stenosis who do not have typical angina symptoms (defined as Canadian Cardiovascular Society Class \<3). "Non-inferior" means the study seeks to show that omitting routine coronary angiography is at least as effective and safe as the standard approach. All participants will receive a CE-certified Myval™ balloon-expandable transcatheter heart valve. This device is commercially available and designed to provide accurate positioning and reliable valve function. This is a multicentre, investigator-initiated clinical study sponsored by Rede Optimus (RO), Alte Steinhauserstrasse 1, 6330 Cham, Switzerland. RO conducts independent research to address unresolved questions in vascular medicine. The study is financially supported by Meril Life Sciences Pvt. Ltd., Bilakhia House, Survey No.135/139, Muktanand Marg, Chala, Vapi 396191, Gujarat, India. Approximately 620 patients will be enrolled across 20 centres in 7 European countries. The total study duration is expected to be 42 months, with an 18-month enrollment period and 24-month follow-up for each participant.

Eligibility

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 and female patient of childbearing potential

Conditions2

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