AltaValve Pivotal Trial Protocol

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and effectiveness of an experimental device called the AltaValve System in people with moderate-to-severe and severe mitral regurgitation. The study aims to determine whether the device can help treat a leaky valve; it involves a procedure that is less invasive than open heart replacement of the mitral valve. Study procedures include transcatheter mitral valve replacement procedure and clinic visits. A smaller study to assess the safety of the AltaValve System was already completed; this study is being conducted to confirm AltaValve System’s long-term effectiveness. The AltaValve is a self-expandable device created to fit the patient’s heart. The tissue valve is a man-made valve that imitates the patient’s own mitral valve leaflets (leaf-like structures that help control the blood flow in the heart). The fabric and tissue are intended to reduce or stop the leakage of the mitral valve.


Eligibility

  • * Age ≥ 18 years.
  • * Symptomatic New York Heart Association (NYHA) class II-IV.
  • * Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
  • * Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

AltaValve Pivotal Trial Protocol

Study Details
Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III

IRB Number

STUDY00003709

ClinicalTrials.gov ID

NCT06465745

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

5472

ClinicalTrials.gov ID

NCT06465745

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org