- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04679662
EXPLORE DMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation
December 21, 2020 updated by: Polares Medical SA
Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation (EXPLORE DMR)
An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe degenerative 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older
- Greater than moderate degenerative 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DEVICE_FEASIBILITY
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single-arm study of PLAR Implant and Delivery System to treat severe mitral regurgitation
All enrolled patients will receive the study device
|
The PLAR Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of all-cause mortality following treatment with the PLAR Implant and Delivery System
Time Frame: 30-days follow-up
|
Primary safety outcome
|
30-days follow-up
|
Incidence of change from severe mitral regurgitation at baseline (Grade 3+ or more) to moderate or less mitral regurgitation (Grade 2+ or less) following treatment with the PLAR Implant and Delivery System as evaluated by 2D TTE
Time Frame: 30-days follow-up
|
Primary performance endpoint
|
30-days follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of major safety events as defined by MVARC2 definitions
Time Frame: Follow-up at 30 days, at 6 and 12 months, and at 2, 3, 4 and 5 years
|
Secondary safety endpoint
|
Follow-up at 30 days, at 6 and 12 months, and at 2, 3, 4 and 5 years
|
Technical success rate per MVARC2 definitions
Time Frame: Technical success is measured immediately following the procedure
|
All of the following must be present for technical success:
|
Technical success is measured immediately following the procedure
|
Procedure success rate per MVARC2 definitions
Time Frame: Procedure success is measured at 30 days follow-up
|
Both of the following must be present for procedure success:
|
Procedure success is measured at 30 days follow-up
|
Device success rate per MVARC 2 definitions
Time Frame: Device success is measured at 30 days, at 6 and 12 months, and at 2, 3, 4, and 5 years follow-up
|
All of the following must be present for device success:
|
Device success is measured at 30 days, at 6 and 12 months, and at 2, 3, 4, and 5 years follow-up
|
Patient success rate per MVARC2 definitions
Time Frame: Patient success is measured at 12 months follow-up
|
All of the following must be present for patient success:
|
Patient success is measured at 12 months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
March 1, 2021
Primary Completion (ANTICIPATED)
March 1, 2022
Study Completion (ANTICIPATED)
December 1, 2026
Study Registration Dates
First Submitted
December 8, 2020
First Submitted That Met QC Criteria
December 21, 2020
First Posted (ACTUAL)
December 22, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 22, 2020
Last Update Submitted That Met QC Criteria
December 21, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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