| NCT ID | NCT07075861 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Policlinico S. Donato |
| Condition | Aortic Regurgitation Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-08-10 |
| Primary Completion | 2028-08-10 |
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 75 participants in total. It began in 2025-08-10 with a primary completion date of 2028-08-10.
⚠ 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
To observe the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with evere native aortic regurgitation (AR) who are indicated for TAVR Data collection
Eligibility Criteria
Inclusion Criteria: * Considered at high or prohibitive risk for surgical aortic valve replacement by the Heart Team * 18 years of age or older * Suitable anatomy according to the IFU * Absence of significant disease of the ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50mm or greater) or atheroma (especially if thick \[\>5mm\], protruding or ulcerated) Exclusion Criteria: The JenaValve Trilogy Heart Valve System is contraindicated for use in patients who have known hypersensitivity or contraindication to Nitinol (titanium and/or nickel), an anti-coagulation/anti-platelet regimen or contrast medium that cannot be managed with premedication, or who have active bacterial endocarditis or other active infections. The JenaValve Trilogy Heart Valve System is contraindicated in those patients whose anatomy does not accommodate the System due to anatomical considerations outlined in the inclusion criteria.
Contact & Investigator
Luca Testa, PI
PRINCIPAL INVESTIGATOR
IRCCS Policlinico San Donato (San Donato Milanese) - IT
Frequently Asked Questions
Who can join the NCT07075861 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Regurgitation Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07075861 currently recruiting?
Yes, NCT07075861 is actively recruiting participants. Contact the research team at federica.rossi@grupposandonato.it for enrollment information.
Where is the NCT07075861 trial being conducted?
This trial is being conducted at San Donato Milanese, Italy.
Who is sponsoring the NCT07075861 clinical trial?
NCT07075861 is sponsored by IRCCS Policlinico S. Donato. The principal investigator is Luca Testa, PI at IRCCS Policlinico San Donato (San Donato Milanese) - IT. The trial plans to enroll 75 participants.