EXPLORE FMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation

NCT ID: NCT04679714

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2026-12-31

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.

Conditions

Functional Mitral Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Single-arm study of PLAR Implant and Delivery System

All enrolled patients will receive the study device

Group Type: EXPERIMENTAL

Transcatheter mitral valve repair (PLAR Implant and Delivery System)

Intervention Type: DEVICE

The PLAR Implant is placed on the mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture

Interventions

Transcatheter mitral valve repair (PLAR Implant and Delivery System)

The PLAR Implant is placed on the mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture

Intervention Type: DEVICE

Other Intervention Names

TMVr

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polares Medical, Inc.

UNKNOWN

Sponsor Role: collaborator

Polares Medical SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura A Brenton

Role: STUDY_DIRECTOR

Polares Medical

Central Contacts

Laura A Brenton

Role: CONTACT

Phone: +1 313 919 8044

Email: lbrenton@polaresmedical.com

Other Identifiers

202004

Identifier Type: -

Identifier Source: org_study_id