Condition: Severe Aortic Stenosis · Sponsor: Rede Optimus Hospitalar SA
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 rec…
This description comes directly from the study's public registry record.
Julie Bosiers · +32 479 64 37 60 · julie.bosiers@redeoptimus.com
Gavin Vaz · 04917615203936 · gavin.vaz@redeoptimus.com
Always discuss trial participation with your own doctor first.
| Medical University Graz | Graz, Austria | Recruiting |
| Klinikum Klagenfurt am Wörthersee | Klagenfurt, Austria | Not Yet Recruiting |
| Královské Vinohrady University Hospital | Prague, Czechia | Not Yet Recruiting |
| Nemocnice Na Homolce | Prague, Czechia | Not Yet Recruiting |
| Institut Arnault Tzanck | Nice, France | Not Yet Recruiting |
| Clinique Pasteur | Toulouse, France | Not Yet Recruiting |
| Universitätsklinikum Düsseldorf | Düsseldorf, North Rhine-Westphalia, Germany | Not Yet Recruiting |
| Elisabeth Krankenhaus Essen | Essen, Germany | Not Yet Recruiting |
| Universitätsklinikum Freiburg- Universitäts-Herzzentrum Campus Bad Krozingen | Freiburg im Breisgau, Germany | Not Yet Recruiting |
| Universitätsklinikum Schleswig-Holstein - Campus Lübeck | Lübeck, Germany | Not Yet Recruiting |
| Universitätsklinikum Ulm | Ulm, Germany | Not Yet Recruiting |
| IRCCS ISMETT Palermo | Palermo, Basel-Stadt, Italy | Not Yet Recruiting |
+ 11 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06898086