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

Primary Purpose

Functional Mitral Regurgitation

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Transcatheter mitral valve repair (PLAR Implant and Delivery System)

About this trial

This is an interventional device feasibility trial for Functional Mitral Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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)
Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated
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
Emergency situations
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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-arm study of PLAR Implant and Delivery System

Arm Description

All enrolled patients will receive the study device

Outcomes

Primary Outcome Measures

Incidence of all-cause mortality

Primary safety outcome

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

Secondary Outcome Measures

Rate of major safety events as defined by MVARC2 definitions

Secondary safety endpoint

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

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

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

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

Full Information

NCT ID

NCT04679714

First Posted

December 8, 2020

Last Updated

December 21, 2020

Sponsor

Polares Medical SA

Collaborators

Polares Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04679714

Brief Title

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

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 2021 (Anticipated)

Primary Completion Date

March 2022 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Polares Medical SA

Collaborators

Polares Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Mitral Regurgitation

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single-arm registry

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single-arm study of PLAR Implant and Delivery System

Arm Type

Experimental

Arm Description

All enrolled patients will receive the study device

Intervention Type

Device

Intervention Name(s)

Transcatheter mitral valve repair (PLAR Implant and Delivery System)

Other Intervention Name(s)

TMVr

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of all-cause mortality

Description

Primary safety outcome

Time Frame

30-days follow-up

Title

Incidence of change from baseline to moderate or less mitral regurgitation (Grade 2+ or less) as evaluated by 2D TTE Primary performance endpoint

Description

Primary performance endpoint

Time Frame

30-days follow-up

Secondary Outcome Measure Information:

Title

Rate of major safety events as defined by MVARC2 definitions

Description

Secondary safety endpoint

Time Frame

Follow-up at 30 days, at 6 and 12 months, and at 2, 3, 4 and 5 years

Title

Technical success rate per MVARC2 definitions

Description

Time Frame

Technical success is measured immediately following the procedure

Title

Procedure success rate per MVARC2 definitions

Description

Time Frame

Procedure success is measured at 30 days follow-up

Title

Device success rate per MVARC 2 definitions

Description

Time Frame

Device success is measured at 30 days, at 6 and 12 months, and at 2, 3, 4, and 5 years follow-up

Title

Patient success rate per MVARC2 definitions

Description

Time Frame

Patient success is measured at 12 months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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) Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated 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 Emergency situations 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laura A Brenton

Phone

+1 313 919 8044

lbrenton@polaresmedical.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura A Brenton

Organizational Affiliation

Polares Medical

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Clinical trial results will be shared with investigators once study is enrolled and trial data is prepared for presentation at a medical conference or for publication in a medical journal.

Learn more about this trial

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

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