CoreValve™ Evolut R™ 34 mm System Registry (CoreValve34)

Launched by FUNDACIN BIOMEDICA GALICIA SUR · Aug 3, 2018

Keywords

ClinConnect Summary

With the current transcatheter valves available in the market, is possible to cover a wide range of patients with diverse and complex anatomies. Nevertheless, there is a subgroup of patient with large aortic annulus (diameter \> 27 mm), in whom the implant of a transcatheter valve is not possible because there is no valve suitable for such as aortic annulus size.

With the introduction of the CoreValveTM EvolutionTM R 34mm, patients with an aorttic annulus dimension up to 29 mm in diameter have become eligible for TAVI. However, there is a lack of information regarding the number of patient...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects ≥ 18 years of age.
• • Subject accepted participate and signed informed consent.
• • Subject with severe symptomatic AS patients selected for TAVI by the Heart Team of each participating hospital.
• • Patients anatomically suitable for the implantation of a CoreValve™ Evolut R™ 34mm with the approved indications by any feasible and appropriate vascular routes.
• • Subject must agree to undergo all follow-up visits
• Exclusion Criteria:
• • High probability of non-adherence to the follow-up requirements.
• • Explicit refusal of participation in the registry.