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

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcatheter aortic valve implantation: Transcatheter aortic valve implantation using the CE-certified Myval™ transcatheter heart valve series

Study 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

Primary outcome measure(s)

• Composite of all-cause death, spontaneous or periprocedural myocardial infarction, etc — at 12-months follow-up
  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

Trial sites (23)

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