SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)

SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)

The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.

Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject has a severe symptomatic AS undergoing a TAVI procedure
3. Subject with a THV for which rapid pacing is considered necessary during valve implantation
4. Subject agrees to participate in the study and is able to sign the informed consent form

Exclusion Criteria:

1. Failure to provide signed informed consent
2. Extremely horizontal aorta (aortic root angle ≥70°)
3. Extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta
4. Inability to receive full anticoagulation during the TAVI procedure
5. Prohibitive surgical risk precluding (according to the Heart Team) conversion to open heart surgery in case of a life-threatening complication.