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Heart valve replacement for severe aortic stenosis with or without a prior artery X-ray

Tests skipping routine coronary angiography before TAVI in people with severe aortic stenosis.

Key facts

Who runs it
Rede Optimus Hospitalar SA
Where
Basel and Zurich, SwitzerlandSee the 2 sitesAlso in 6 other countries, 21 sites
Trial code
Registry title
Transfemoral TAVI With or Without Coronary Angiogram in Patients With Severe Aortic Stenosis (PURE TAVI)
Status
Enrolling by invitation
People taking part
620 people, planned
Started
8 Aug 2025
Expected to end
31 May 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Transcatheter aortic valve implantation
Record updated
25 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe aortic stenosis (a narrowed heart valve) who are planned for TAVI through the groin artery. It compares TAVI with or without a coronary angiogram (an X-ray dye test of the heart arteries) beforehand.

Age
Older than 18 years.
Sex
All sexes can join.
Disease stage
Severe aortic stenosis. A heart team must consider the person for TAVI through the femoral (groin) artery. Chest pain must be below CCS class 3.
Earlier treatment
No coronary angiogram, PCI (stent), coronary CT or bypass surgery (CABG) in the last 5 years. No earlier PCI of the left main artery. No earlier aortic valve implantation or replacement.

Main reasons for not taking part

  • Left ventricular ejection fraction (heart pumping strength) <30%.
  • Treated for a heart attack within 30 days before randomization.
  • Planned open-heart surgery, or TAVI through the groin not possible.
  • Life expectancy less than 1 year due to another severe non-heart disease.
  • Pregnant women and women who could become pregnant.

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patient has been treated for acute myocardial infarction within 30 days before randomization
  • 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
  • Patient has a planned open-heart surgery
  • Patient has a life expectancy less than 1 year due to other severe non-cardiac disease
  • Patient has left ventricular ejection fraction <30%
  • 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
  • Patients in whom TAVI through femoral access is ad priori not possible based on clinical assessment or medical history
  • Female patient who is pregnant at the time of inclusion and female patient of childbearing potential

Where in Switzerland

Also in 6 other countries, 21 sites

  • University Hospital BaselBasel, SwitzerlandEnrolling by invitation
  • University Hospital ZurichZurich, SwitzerlandEnrolling by invitation

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Experimental groupTreatment being tested

    (omission of coronary angiography prior to or during TAVI, unless suspicion of potentially revascularization-indicating stenosis of the left main stem based on the TAVI-CT);

    Treatment: Transcatheter aortic valve implantation

  • Control groupExisting treatment, for comparison

    (coronary angiography with or without PCI prior to TAVI).

    Treatment: Transcatheter aortic valve implantation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Treatment of Severe Aortic Stenosis With Transfemoral TAVI With or Without Coronary Angiogram During Diagnostic Work-up (PURE TAVI)
Plain-language title
Heart valve replacement for severe aortic stenosis with or without a prior artery X-rayGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
25 August 2026