INTENSIVE is a prospective, single-arm, multi-center, international, investigator-initiated study of the Navitor/Navitor Vision Transcatheter Aortic Valve (Navitor/Navitor Vision Valve) in patients with symptomatic, severe native aortic stenosis to monitor the outcomes of this valve in a real-world clinical setting.
Subject is referred to undergo TAVI with a Navitor/Navitor Vision valve according to the local Heart Team. The Heart Team determines the indication for TAVI with Navitor/Navitor Vision before possible enrolment and independently of the study.
Subject is of legal age for consent in the host country.
Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical site.
Pregnant or nursing subjects
Need for emergency surgery for any reason
Any sepsis, including active endocarditis
Any evidence of left ventricular or atrial thrombus
This Study will enroll subjects of all genders who have symptomatic severe AS, either in a native valve or in a surgical bioprosthetic valve, and who have an indication for TAVI. The latter may also be predominantly regurgitant and remain suitable for enrolment.
Cohort
Prospective
Not listed
All-Cause Mortality
The primary endpoint is all-cause mortality at 12 months after the index Navitor/Navitor Vision implantation procedure.
Valve Academic Research Consortium 3 (VARC-3) event definitions
Secondary (Descriptive) Endpoints: The rate of the following key outcomes for the Study will be assessed as descriptive endpoints: 1. Composite of all-cause mortality, fatal stroke/stroke with disability, type 3/type 4 bleeding, stage 3/stage 4 acute kidney injury, major vascular complications, or major access-related non-vascular complications at 30 days 2. Composite of all-cause mortality or all stroke at 12 months 3. Procedural success defined as successful vascular access, delivery and deployment of the Valve; retrieval of the delivery system and correct positioning of a single Valve in the proper anatomical location and the absence of procedural mortality 4. Mortality at 30 days and 12 months 5. Stroke at 30 days and 12 months 6. Transient ischemic attack (TIA) at 30 days and 12 months 7. Bleeding 8. Major vascular complications at 30 days 9. Major access-related non-vascular complications at 30 days 10. Major cardiac complications at 30 days
Valve Academic Research Consortium 3 (VARC-3) event definitions
11\. Acute kidney injury (stage 4, stage 3, and stage 2) at 30 days 12. Permanent pacemaker insertion at 30 days and 12 months 13. Myocardial infarction at 30 days and 12 months 14. Coronary obstruction requiring intervention at 30 days and 12 months 15. Difference in coronary artery cannulation time before versus after Navitor/Navitor Vision implantation 16. Differences in outcome of PVL, embolization/migration 17. Assessment of PM dependency at 3 months after implantation 18. Vascular access complication rate according to the "Hostile Score" 19. Changes in functional status from baseline to follow-up assessments at 30 days and 12 months (e.g., New York Heart Association (NYHA) functional classification, quality of life measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)) 20. Rehospitalization (procedure-related or valve-related hospitalization, and other cardiovascular hospitalization) at 30 days and 12 months
Valve Academic Research Consortium 3 (VARC-3) event definitions
21\. Paravalvular leak (none/trace, mild, moderate or severe) at discharge, 30 days, 12 months and annually (when collected) through 5 years 22. Changes in echocardiographic parameters from baseline to follow-up at 30 days, 12 months and annually (when collected) through 5 years (e.g., mean effective orifice area, mean transvalvular gradient) 23. Aortic valve reintervention at 30 days, 12 months, and annually through 5 years 24. Prosthetic valve endocarditis at 12 months and annually through 5 years 25. Structural valve deterioration at 12 months and annually through 5 years 26. Non-structural valve dysfunction at 12 months and annually through 5 years 27. Successful coronary access as needed at 12 months and annually through 5 years 28. Clinically significant prosthetic valve thrombosis at 12 months and annually through 5 years
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