Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation ( EXPLORE FMR ) (EXPLORE FMR)
Primary Purpose
Functional Mitral Regurgitation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcatheter mitral valve repair
Sponsored by
About this trial
This is an interventional device feasibility trial for Functional Mitral Regurgitation
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
- 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 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 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
Sites / Locations
- Emory MidtownRecruiting
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
Secondary Outcome Measures
Rate of major safety events as defined by MVARC2 definitions
Secondary safety endpoint
Technical success rate per MVARC2 definitions
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
Device success and 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 must be present for 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:
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 must be present for 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
1. Study Identification
Unique Protocol Identification Number
NCT04666467
Brief Title
Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation ( EXPLORE FMR )
Acronym
EXPLORE FMR
Official Title
Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Functional Mitral Regurgitation (EXPLORE FMR)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polares Medical SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
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 up to 4 centers in North America.
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 of the mitral valve. 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
Other Intervention Name(s)
TMVr
Intervention Description
Transvenous approach with a transeptal puncture to place the study device
Primary Outcome Measure Information:
Title
Incidence of all-cause mortality
Description
Primary safety outcome
Time Frame
30-days
Title
Incidence of change from baseline to moderate or less mitral regurgitation (Grade 2+ or less) as evaluated by 2D TTE
Description
Primary performance endpoint
Time Frame
30-days
Secondary Outcome Measure Information:
Title
Rate of major safety events as defined by MVARC2 definitions
Description
Secondary safety endpoint
Time Frame
30 days, at 6 and 12 months, and at 2 - 5 years
Title
Technical success rate per MVARC2 definitions
Description
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
Time Frame
Technical success is measured at exit from OR
Title
Procedure success rate per MVARC2 definitions
Description
Device success and 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
Time Frame
Procedure success is measured at 30 days post-intervention
Title
Device success rate per MVARC 2 definitions (all must be present for success)
Description
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:
No evidence of structural or functional failure
No device technical failure issues/complications
MR reduction to moderate or less without stenosis
Time Frame
Device success is measured at 30 days, at 6 and 12 months, and at 2 - 5 years post-intervention
Title
Patient success rate per MVARC2 definitions (all must be present for success)
Description
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
Time Frame
Patient success is measured at 12 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura A Brenton
Phone
313-919-8044
Email
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
Facility Information:
Facility Name
Emory Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Greenbaum, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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
Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation ( EXPLORE FMR )
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