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

NCT04679662 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 202003
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Degenerative Mitral Valve Disease

Outcome Measures

Primary Outcomes (2)

• Incidence of all-cause mortality following treatment with the PLAR Implant and Delivery System

  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

  Primary performance endpoint

  30-days follow-up

Secondary Outcomes (5)

• Rate of major safety events as defined by MVARC2 definitions

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

• Technical success rate per MVARC2 definitions

  Technical success is measured immediately following the procedure

• Procedure success rate per MVARC2 definitions

  Procedure success is measured at 30 days follow-up

• Device success rate per MVARC 2 definitions

  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

  Patient success is measured at 12 months follow-up

Study Arms (1)

Single-arm study of PLAR Implant and Delivery System to treat severe mitral regurgitation

EXPERIMENTAL

All enrolled patients will receive the study device

Device: Transcatheter mitral valve repair (PLAR Implant and Delivery System)

Interventions

Transcatheter mitral valve repair (PLAR Implant and Delivery System) DEVICE

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

Also known as: TMVr

Single-arm study of PLAR Implant and Delivery System to treat severe mitral regurgitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Polares Medical SA: lead
• Polares Medical, Inc.: collaborator

Study Officials

• Laura A Brenton

  Polares Medical

  STUDY DIRECTOR

Central Study Contacts

Laura A Brenton

CONTACT

+1 313 919 8044; lbrenton@polaresmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm registry

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 22, 2020
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share