NCT06008080 Post-Market Clinical Follow Up Study With Navitor Valve
| NCT ID | NCT06008080 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Aortic Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-09-29 |
| Primary Completion | 2027-07 |
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 1,000 participants in total. It began in 2023-09-29 with a primary completion date of 2027-07.
⚠ 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
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
Eligibility Criteria
Inclusion Criteria: * Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure. * The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the IRB (Investigational Review Board)/EC (Ethics Committee) of the respective clinical site. * The patient and the treating physician agree that the subject will return for all required post procedure follow up visits. Exclusion Criteria: * Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU) * Life expectancy \< 12 months from the time of informed consent due to non-cardiac co-morbid conditions. * In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study. * Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated. * Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated. * Currently participating in an investigational drug or device study that may confound the results of this study * Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible
Contact & Investigator
Alper Öner, MD
PRINCIPAL INVESTIGATOR
Universitätsmedizin Rostock, Germany
Frequently Asked Questions
Who can join the NCT06008080 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06008080 currently recruiting?
Yes, NCT06008080 is actively recruiting participants. Contact the research team at bart.janssens@abbott.com for enrollment information.
Where is the NCT06008080 trial being conducted?
This trial is being conducted at Adelaide, Australia, Hobart, Australia, Melbourne, Australia, Massy, France and 11 additional locations.
Who is sponsoring the NCT06008080 clinical trial?
NCT06008080 is sponsored by Abbott Medical Devices. The principal investigator is Alper Öner, MD at Universitätsmedizin Rostock, Germany. The trial plans to enroll 1,000 participants.