Edwards_#2021-05_ALLIANCE Sapien X4

Summary

The study will use the study device (Sapien X4) in patients with severe Aortic Stenosis; it study the device's safety and effectiveness


Inclusion Criteria

  • Severe, calcific AS
  • Native aortic annulus size suitable for SAPIEN X4 THV
  • NYHA functional class ≥ II
  • The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

Safety and Effectiveness of Balloon-Expanding Bioprosthetic Sapien X4 Trascather Heart Valve -ALLIANCE Study

Details
Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III

IRB Number

STUDY00002097

ClinicalTrials.gov ID

NCT05172960

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III

IRB Number

2021-05

ClinicalTrials.gov ID

NCT05172960

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?