Navitor TAVI System for Severe Aortic Stenosis in Japanese Patients
Data Collection
Collected from today forward - ProspectiveAortic Valve Disease+3
+ Aortic Valve Stenosis
+ Cardiovascular Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 30, 2025
Actual date on which the first participant was enrolled.This study focuses on understanding the safety and performance of a medical device called the Navitor TAVI system, which is used to treat individuals with severe aortic stenosis. Aortic stenosis is a condition where the heart's aortic valve narrows, making it difficult for blood to flow through the heart. This study is particularly interested in observing how this device works in about 100 Japanese patients who are already experiencing symptoms of this condition. The findings from this study could help improve treatment for aortic stenosis by providing insights into how well the Navitor TAVI system works in real-world settings, potentially leading to better patient care. Participants in this study will have the Navitor TAVI system implanted, and researchers will monitor their progress at different stages: right after they leave the hospital, then 30 days, and again one year after the procedure. The study does not involve any experimental treatments but instead observes the outcomes of using this device in a typical medical setting. By carefully checking on the patients at these intervals, the study aims to gather detailed information about the device's effectiveness and any safety concerns, helping doctors understand its benefits and any potential risks.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 100 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure. 2. 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 EC of the respective clinical site. 3. The patient and the treating physician agree that the subject will return for all required post-procedure follow-up visits Exclusion Criteria: 1. Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU). 2. Life expectancy \< 12 months from the time of informed consent due to non-cardiac co-morbid conditions. 3. 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. 4. Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated. 5. Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated. 6. Currently participating in an investigational drug or device study that may confound the results of this study. 7. Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location