CSTN: PRIMARY

What is the Purpose of this Study?

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.

Eligibility

* 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

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
* Patients across the surgical risk spectrum (low, intermediate, and high risk) depending on the local heart team assessment (see 2020 ACC/AHA guidelines for the management of patients with valvular heart disease)
* Patients with AF who meet an indication for concomitant ablation may be included provided the local heart team verifies they are eligible for both catheter-based and surgical ablation.
* Ability to perform 6-minute walk test (6MWT) and complete Kansas City Cardiomyopathy Questionnaire (KCCQ) instrument

Exclusion Criteria:

* Non-degenerative types of primary MR (e.g., cleft leaflet)
* Secondary or functional MR
* Hypertrophic obstructive cardiomyopathy
* Presence of an IVC filter or pacing/ICD leads that would interfere with TEER per local heart team assessment
* Known allergic reactions to intravenous contrast
* Febrile illness within 30-days prior to randomization
* Any absolute contraindication to transesophageal echocardiography
* Any contraindication to systemic heparinization including active bleeding diatheses, and heparin induced thrombocytopenia
* Patients with CAD requiring revascularization
* Any prior mitral valve intervention or any prior repair of atrial septal defect
* Any prior MV intervention or any prior repair of atrial septal defect
* Need for any of the following concomitant procedures: aortic valve or aortic surgery, tricuspid valve surgery
* Need for any emergency intervention or surgery
* Active endocarditis
* Hemodynamic instability defined as cardiac index \<2.0 l/min/m2 or systolic blood pressure \<90mmHg or need for inotropic support or any mechanical circulatory support
* Left ventricular ejection fraction \<25%
* Intracardiac mass or thrombus
* Co-morbid medical or oncologic condition for which local heart team believes that meaningful survival beyond 2 years is unlikely
* Active substance abuse
* Suspected inability to adhere to follow-up
* Treatment with another investigational drug or other intervention, assessment of which has not completed its primary endpoint or that clinically interferes with the present study endpoints.

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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

Study 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

How do I learn more about this study?

clinicaltrials@cshs.org