Condition: Aortic Diseases · Sponsor: Biosensors Europe SA
This clinical investigation is being done to evaluate the safety and effectiveness of a new device, a PTV Balloon, that will be used to open up an area in the heart (the valve) before and potentially after placing a new valve in patients requiring a new heart valve. The main question it aims to answer is: What percentage of patients develop new heart conduction problems after using the investigational PTV Balloon for pre-dilatation? Participants will: 1. Undergo a TAVI procedure, where the PTV Balloon will be used for pre-dilatation and may also be used for post-dilatation. 2. Will be followed up until discharge or up to 7 days, whichever happens first.
This description comes directly from the study's public registry record.
Anders Jönsson · 0041218048000 · a.jonsson@biosensors.com
Diana Schuette · 00447970942022 · d.schuette@biosensors.com
Always discuss trial participation with your own doctor first.
| Hospital de la Santa Creu i Sant Pau | Barcelona, Spain | Recruiting |
| Hospital Universitari de Bellvitge | Barcelona, Spain | Recruiting |
| Hospital Universitario Reina Sofia | Córdoba, Spain | Recruiting |
| Hospital Universitario Juan Ramon Jimenez | Huelva, Spain | Recruiting |
| Hospital Universitario Ramon y Cajal | Madrid, Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid, Spain | Recruiting |
| Hospital Universitario Virgen del Rocio | Seville, Spain | Recruiting |
| Hospital Universitario y Politécnico La Fe | Valencia, Spain | Recruiting |
| Hospital Clínico Universitario de Valladolid (HCUV) | Valladolid, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06816485