Clinical trial NCT04679714: EXPLORE FMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation
Official title: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation (EXPLORE FMR)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Mitral Regurgitation
Lead sponsor: Polares Medical SA
Sponsor class: INDUSTRY
Collaborators: name: Polares Medical, Inc.
First posted: 2020-12-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm registry
Primary purpose: DEVICE_FEASIBILITY

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 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 one (1) center in Brazil.

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 patients with severe MR who are refused or denied surgery due to high risk. Percutaneous therapy provides a novel alternative treatment option for these patients with the aim of reducing morbidity and mortality over and above current medical therapy. The Polares Medical PLAR Implant and Delivery System is a catheter-based technology designed to permanently implant a prosthesis using a transvenous / transseptal approach to augment the posterior mitral valve leaflet and improve coaptation with the anterior leaflet. Approved edge-to-edge repair has already been shown to be a viable alternative for high risk MR patients. However treatment with these devices is limited to specific anatomies and often requires multiple devices which increases clinical risk, adds to procedural time, and can result in residual MR. The PLAR Implant and Delivery System has been designed to overcome and mitigate some of these shortfalls.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Greater than moderate functional mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
3. Patient must present with an STS Score less than 10%
4. 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
5. New York Heart Association (NYHA) Functional Class III or IV
6. Patient willing to participate in study and provide signed IRB/EC-approved informed consent
7. Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits

Exclusion Criteria:

1. Severe tricuspid regurgitation
2. Severe aortic stenosis or insufficiency
3. Severe mitral annulus calcification
4. Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
5. Implanted vena cava filter
6. Femoral veins with severe angulation and calcification
7. Contraindication for transesophageal echocardiography (TEE) or MDCT scan
8. Active infection or endocarditis
9. Previous mitral valve surgery
10. Prior orthotopic heart transplantation
11. Pulmonary artery systolic hypertension \> 70mmHg
12. Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus
13. Left ventricular ejection fraction (LVEF) \< 30%
14. Implant or revision of any pacing device \< 30 days prior to intervention
15. Symptomatic coronary artery disease treated \< 30 days prior to study procedure
16. Myocardial infarction requiring intervention \< 30 days prior to study procedure
17. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis
18. Active peptic ulcer or upper gastrointestinal bleeding \< 90 days prior to study procedure
19. Stroke \< 180 days prior to study procedure
20. Severe renal insufficiency (creatinine \> 3.0 mg/dL) or patient requiring dialysis
21. Cardiogenic shock at time of enrolment
22. Hemodynamic instability requiring inotropic support or mechanical heart assistance
23. Concurrent medical condition with a life expectancy of less than 2 years
24. Pregnancy at time of enrolment
25. 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)
26. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated
27. 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
28. Emergency situations
29. Company employees or their immediate family members
30. Patient is under guardianship
31. Patient is participating in another clinical study for which follow-up is currently ongoing

Primary outcomes:
measure: Incidence of all-cause mortality
timeFrame: 30-days follow-up
measure: Incidence of change from baseline to moderate or less mitral regurgitation (Grade 2+ or less) as evaluated by 2D TTE Primary performance endpoint
timeFrame: 30-days follow-up
Secondary outcomes:
measure: Rate of major safety events as defined by MVARC2 definitions
timeFrame: Follow-up at 30 days, at 6 and 12 months, and at 2, 3, 4 and 5 years
measure: Technical success rate per MVARC2 definitions
timeFrame: Technical success is measured immediately following the procedure
measure: Procedure success rate per MVARC2 definitions
timeFrame: Procedure success is measured at 30 days follow-up
measure: Device success rate per MVARC 2 definitions
timeFrame: Device success is measured at 30 days, at 6 and 12 months, and at 2, 3, 4, and 5 years follow-up
measure: Patient success rate per MVARC2 definitions
timeFrame: Patient success is measured at 12 months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Polares Medical
name: Laura A Brenton
role: STUDY_DIRECTOR
References: