Status:
WITHDRAWN
Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation ( EXPLORE FMR )
Lead Sponsor:
Polares Medical SA
Conditions:
Functional Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe functional mitral regurgitation and to gather preliminary data on its performa...
Detailed Description
Percutaneous approaches to treat MR promise to provide a sufficient reduction in MR without the risks typically associated with open heart surgery. Furthermore there is an unmet clinical need for pati...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Greater than moderate functional 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 sign the 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
Exclusion
- 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 enrollment
- 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 enrollment
- 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)
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated
- Emergency situations
- Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments
- Company employees or their immediate family members
- Patient is under guardianship
- Patient is participating in another clinical study for which follow-up is currently ongoing
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04666467
Start Date
April 1 2021
End Date
December 31 2022
Last Update
December 20 2023
Active Locations (1)
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1
Emory Midtown
Atlanta, Georgia, United States, 30308