Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation

Stopped early · Not applicable

Conditions studied: Degenerative Mitral Valve Disease

In brief

An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe degenerative mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 10 patients at up to 4 centers in North America.

Key facts

Study ID

NCT04666480

Run by

Polares Medical SA

People needed

1

Starts

2021-04-30

Expected to finish

2022-12-31

Last updated by the study team

2023-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Greater than moderate degenerative mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
• Patient must present with an STS Score less than 10%
• High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
• Patient is approved by an independent Patient Eligibility Committee
• New York Heart Association (NYHA) Functional Class III or IV
• Patient willing to participate in study and provide signed IRB/EC-approved informed consent
• Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits
• Women of child-bearing potential have a negative pregnancy test

You may not qualify if…

• Severe tricuspid regurgitation
• Severe aortic stenosis or insufficiency
• Severe mitral annulus calcification
• Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
• Implanted vena cava filter
• Femoral veins with severe angulation and calcification
• Contraindication for transesophageal echocardiography (TEE) or MDCT scan.
• Active infection or endocarditis
• Previous mitral valve surgery
• Prior orthotopic heart transplantation
• Pulmonary artery systolic hypertension > 70mmHg
• Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus
• Left ventricular ejection fraction (LVEF) < 30%
• Implant or revision of any pacing device < 30 days prior to intervention
• Symptomatic coronary artery disease treated < 30 days prior to study procedure
• Myocardial infarction requiring intervention < 30 days prior to study procedure
• Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis
• Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to study procedure
• Stroke < 180 days prior to study procedure
• Severe renal insufficiency (creatinine > 3.0 mg/dL) or patient requiring dialysis
• Cardiogenic shock at time of enrolment
• Hemodynamic instability requiring inotropic support or mechanical heart assistance
• Concurrent medical condition with a life expectancy of less than 2 years
• Pregnancy at time of enrolment
• History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3,000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL)

Where it is running

• Emory Midtown — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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