NCT07120048 Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
| NCT ID | NCT07120048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edwards Lifesciences |
| Condition | Aortic Valve Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-07-30 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Collect real-world data on hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A, in subjects requiring replacement of their native or prosthetic aortic valve as the only heart valve procedure during the index procedure, with or without other concomitant procedures.
Eligibility Criteria
Inclusion Criteria: 1. Patients requiring an aortic valve replacement using the INSPIRIS RESILIA aortic valve according to its intended purpose 2. Patients with standard-of-care pre-procedure imaging evaluation (echocardiography and CT) data available 3. Age ≥ 18 years 4. Provision of written informed consent Exclusion Criteria: 1. Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery 2. Emergency procedure 3. Patients requiring a non-aortic heart valve procedure during the index procedure
Contact & Investigator
Torsten Doenst, Prof. Dr. med.
PRINCIPAL INVESTIGATOR
Jena University Hospital, University of Jena
Frequently Asked Questions
Who can join the NCT07120048 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07120048 currently recruiting?
Yes, NCT07120048 is actively recruiting participants. Contact the research team at sabrina_hundt@edwards.com for enrollment information.
Where is the NCT07120048 trial being conducted?
This trial is being conducted at Heidelberg, Germany, Bad Neustadt an der Saale, Germany, Erlangen, Germany, Munich, Germany and 10 additional locations.
Who is sponsoring the NCT07120048 clinical trial?
NCT07120048 is sponsored by Edwards Lifesciences. The principal investigator is Torsten Doenst, Prof. Dr. med. at Jena University Hospital, University of Jena. The trial plans to enroll 500 participants.