4CMedicalTechnologies_5472_AltaValve Pivotal

What is the Purpose of this Study?

The purpose of this clinical trial is to evaluate the safety and effectiveness of the AltaValve System in treatment of moderate-to-severe and severe mitral regurgitation in target patient population.


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?

Cedars Sinai Medical Center

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