Post-Market Clinical Follow Up Study With Navitor Valve

Launched by ABBOTT MEDICAL DEVICES · Aug 16, 2023

Keywords

ClinConnect Summary

The Navitor Valve clinical trial is studying the safety and effectiveness of a new heart valve system called the Navitor TAVI (Transcatheter Aortic Valve Implantation) for patients with a condition known as aortic stenosis, which narrows the heart's aortic valve and can cause serious health issues. This global study is currently looking for participants aged between 65 and 74 years, and it welcomes individuals of all genders. To be eligible, patients need to be scheduled for the Navitor procedure, have a clear understanding of the study, and agree to attend all follow-up appointments after the procedure.

Participants can expect to be monitored closely after their procedure to ensure everything is working well and to collect important data about the valve's performance. It's important to note that individuals with a life expectancy of less than 12 months due to other health conditions or those currently involved in other clinical studies may not qualify for this trial. By participating, patients will help researchers learn more about this new valve system and potentially improve treatment options for others with aortic stenosis.

Gender

ALL

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