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

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Austria
Medical University Graz
RECRUITING
Graz
Klinikum Klagenfurt am Wörthersee
NOT_YET_RECRUITING
Klagenfurt
France
Institut Arnault Tzanck
NOT_YET_RECRUITING
Nice
Clinique Pasteur
NOT_YET_RECRUITING
Toulouse
Germany
Universitätsklinikum Düsseldorf
NOT_YET_RECRUITING
Düsseldorf
Elisabeth Krankenhaus Essen
NOT_YET_RECRUITING
Essen
Universitätsklinikum Freiburg- Universitäts-Herzzentrum Campus Bad Krozingen
NOT_YET_RECRUITING
Freiburg Im Breisgau
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
NOT_YET_RECRUITING
Lübeck
Universitätsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Italy
Azienda Ospedaliero Policlinico Universitaria G. Rodolico- San Marco Catania
NOT_YET_RECRUITING
Catania
Ospedale dell'Angelo - ULSS 3 Serenissima
NOT_YET_RECRUITING
Mestre
IRCCS ISMETT Palermo
NOT_YET_RECRUITING
Palermo
AOUP- Azienda Ospedaliera Universitaria Pisana
NOT_YET_RECRUITING
Pisa
Fondazione Policlinico Universitario Campus Biomedico
RECRUITING
Roma
Azienda Ospedaliera Universitaria Senese
NOT_YET_RECRUITING
Siena
Azienda Sanitaria Universitaria Integrata di Trieste
NOT_YET_RECRUITING
Trieste
Netherlands
OLVG Hospital Amsterdam
NOT_YET_RECRUITING
Amsterdam
Stichting Amsterdam UMC
NOT_YET_RECRUITING
Amsterdam
Clinical Trial Center Maastricht B.V
NOT_YET_RECRUITING
Maastricht
Switzerland
University Hospital Basel
RECRUITING
Basel
University Hospital Zurich
NOT_YET_RECRUITING
Zurich
Contact Information
Primary
Julie Bosiers
julie.bosiers@redeoptimus.com
+32 479 64 37 60
Backup
Gavin Vaz
gavin.vaz@redeoptimus.com
04917615203936
Time Frame
Start Date: 2025-08-08
Estimated Completion Date: 2028-10-30
Participants
Target number of participants: 620
Treatments
Experimental: Experimental group
(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);
Active_comparator: Control group
(coronary angiography with or without PCI prior to TAVI).
Sponsors
Leads: Rede Optimus Hospitalar SA

This content was sourced from clinicaltrials.gov