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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04679714
Other study ID # 202004
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2021
Est. completion date December 2026

Study information

Verified date December 2020
Source Polares Medical SA
Contact Laura A Brenton
Phone +1 313 919 8044
Email lbrenton@polaresmedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date December 2026
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Polares Medical SA Polares Medical, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of all-cause mortality Primary safety outcome 30-days follow-up
Primary Incidence of change from baseline to moderate or less mitral regurgitation (Grade 2+ or less) as evaluated by 2D TTE Primary performance endpoint Primary performance endpoint 30-days follow-up
Secondary Rate of major safety events as defined by MVARC2 definitions Secondary safety endpoint Follow-up at 30 days, at 6 and 12 months, and at 2, 3, 4 and 5 years
Secondary Technical success rate per MVARC2 definitions All of the following must be present for technical success:
Absence of procedure mortality
Successful access, delivery and retrieval of investigation delivery system
Successful deployment and correct positioning of intended implant(s)
Freedom from emergency surgery/re-intervention related to device or access procedure
Technical success is measured immediately following the procedure
Secondary Procedure success rate per MVARC2 definitions Both of the following must be present for procedure success:
Device success
Absence of major device or procedure-related serious adverse events as below:
Death
Stroke
Life-threatening bleed
Major vascular complication
Major cardiac structural complication
Stage 2 or 3 AKI
MI or coronary ischemia requiring PCI or CABG
Shock, heart or respiratory failure requiring IV vasopressors, mechanical intervention or prolonged intubation
Valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Procedure success is measured at 30 days follow-up
Secondary Device success rate per MVARC 2 definitions All of the following must be present for device success:
Absence of procedure mortality or stroke
Proper placement and positioning of device
Freedom from unplanned re-intervention related to device or access procedure • Continued intended safety and performance of the device as below:
No evidence of structural or functional failure
No device technical failure issues/complications
MR reduction to moderate or less without stenosis
Device success is measured at 30 days, at 6 and 12 months, and at 2, 3, 4, and 5 years follow-up
Secondary Patient success rate per MVARC2 definitions All of the following must be present for patient success:
Device success
Patient returned to pre-procedure setting
No rehospitalization or reintervention for mitral regurgitation or heart failure
Functional improvement from baseline by one or more NYHA class
6MWT improvement from baseline by 50 metres or more
Patient success is measured at 12 months follow-up
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