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

NCT04666467 | Withdrawn DMC FDA Device

• 1 other identifier: 202002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

• Incidence of all-cause mortality

  Primary safety outcome

  30-days

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

  Primary performance endpoint

  30-days

Secondary Outcomes (5)

• Rate of major safety events as defined by MVARC2 definitions

  30 days, at 6 and 12 months, and at 2 - 5 years

• Technical success rate per MVARC2 definitions

  Technical success is measured at exit from OR

• Procedure success rate per MVARC2 definitions

  Procedure success is measured at 30 days post-intervention

• Device success rate per MVARC 2 definitions (all must be present for success)

  Device success is measured at 30 days, at 6 and 12 months, and at 2 - 5 years post-intervention

• Patient success rate per MVARC2 definitions (all must be present for success)

  Patient success is measured at 12 months post-intervention

Study Arms (1)

Single-arm study of PLAR Implant and Delivery System

EXPERIMENTAL

All enrolled patients will receive the study device

Device: Transcatheter mitral valve repair

Interventions

Transcatheter mitral valve repair DEVICE

Transvenous approach with a transeptal puncture to place the study device

Also known as: TMVr

Single-arm study of PLAR Implant and Delivery System

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 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

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

Study Sites (1)

Emory Midtown

Atlanta, Georgia, 30308, United States

Location

Study Officials

• Laura A Brenton

  Polares Medical

  STUDY DIRECTOR

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 1, 2020
• First Posted: December 14, 2020
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)