CSTN: PRIMARY

Summary

The purpose of this study is to compare the risks and benefits of two procedures used to help patients with mitral valve regurgitation (MR). MR is a condition in which the heart valve does not close fully, and blood can then leak back into the left atrium instead of circulating to the rest of the body. The study will compare transcatheter edge-to-edge repair (TEER- a catheter procedure for repairing the mitral valve that does not require surgery to open up the heart) and mitral valve repair surgery, an open-heart surgical procedure. Both treatments are well-established and regularly performed in patients who have MR. However, the U.S. Food and Drug Administration (FDA) has not approved the investigational catheter device used in the TEER repair procedure for all types of patients with MR. Participants will be randomly assigned to receive either TEER or mitral valve repair surgery.


Inclusion Criteria

  • Adult patients ≥65 yrs with moderately-severe or severe (3+ or 4+/4+) primary degenerative (Carpentier type II) MR defined by transthoracic echocardiography
  • Clinical indication for MV intervention and anatomic candidate for both MV transcatheter edge-to-edge and surgical repair per local heart team assessment
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for >65 Year-olds

Details
Disease Type/Condition

Valvular Heart Disease

Principal Investigator

Chikwe, Joanna

Age Group

Adult

Phase

N/A

IRB Number

STUDY00001729

ClinicalTrials.gov ID

NCT05051033

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

Valvular Heart Disease

Principal Investigator

Chikwe, Joanna

Age Group

Adult

Phase

N/A

IRB Number

PRIMARY

ClinicalTrials.gov ID

NCT05051033

Key Eligibility
ClinicalTrials.gov

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