Aortic Stenosis: Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve

What is the Purpose of this Study?

The purpose of this study is to determine whether an investigational device called the Sapien X4 Transcatheter Heart Valve system is beneficial for patients with symptomatic, severe, calcific aortic stenosis. Aortic stenosis is a condition in which the opening of the heart valve becomes smaller, making it more difficult for the heart to pump blood. In this study, participants will have their valve replaced by the Sapien X4 Transcatheter Heart Valve system, which includes an artificial heart valve and accessories used to implant the valve. Each valve consists of a stent (metal mesh tube) made of a metal frame with knitted fabric covering some of the frame. The SAPIEN X4 delivery system consists of a catheter (a long, thin, bendable tube that is placed in a blood vessel) that is inserted through an incision made in the groin and moved through blood vessels to the heart.


Eligibility

  • 1. Severe, calcific AS
  • 2. Native aortic annulus size suitable for SAPIEN X4 THV
  • 3. NYHA functional class ≥ II
  • 4. 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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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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

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

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
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
Email
clinicaltrials@cshs.org