Navitor Japan Post-Market Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY
The Navitor Japan Study is designed to evaluate the safety and performance of the Navitor™ valve used in combination with the FlexNav™ delivery system in a contemporary, real-world setting.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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 EC 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
Locations
Other Locations
Japan
Osaka Keisatsu Hospital
RECRUITING
Osaka
Contact Information
Primary
Bart Janssens
bart.janssens@abbott.com
+32471723201
Backup
Alicia Kimber
alicia.kimber@abbott.com
+1 415-917-9696
Time Frame
Start Date: 2025-10-30
Estimated Completion Date: 2027-03
Participants
Target number of participants: 100
Treatments
Cohort 1
This study will enroll subjects of all genders from the population of patients qualifying for TAVI.
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices