Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Mitral Regurgitation

NCT04098328 | Terminated DMC

• 1 other identifier: 201901
• Study Type: observational
• Target: 2
• Locations: 2 countries
• Sites: 3

Brief Summary

Early feasibility study, single-arm registry design

Conditions

Mitral Regurgitation; Mitral Valve Disease; Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (2)

• Primary safety endpoint

  All-cause mortality

  30 days

• Improvement from baseline mitral regurgitation

  Grade 2+ or less as evaluated by 2D transthoracic echocardiography

  30 days

Secondary Outcomes (5)

• Technical success according to MVARC2 criteria

  24 hours

• Procedure success according to MVARC2 criteria

  30 days

• Device success according to MVARC2 criteria

  30 days, 6 and 12 months, and 2 - 5 years post treatment

• Patient success according to MVARC2 criteria

  30 days, 6 and 12 months, and 2 - 5 years post treatment

• Rate (%) of major adverse events as defined by MVARC2 criteria

  Procedure, discharge/7 days, 30 days, 6 and 12 months, and 2 - 5 years post treatment

Eligibility Criteria

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

Study Population

Inoperable or high surgical risk patients with symptomatic degenerative or functional mitral regurgitation (Grade 3+ or higher) with mitral valve anatomy deemed unsuitable, or off-label, to be treated with an approved edge-to-edge repair system.

You may qualify if:

• years of age or older.
• Greater than moderate degenerative or 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) 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
• Mitral valve anatomy deemed unsuitable to be treated with an approved edge-to-edge repair system (e.g., retracted posterior leaflet, lack of leaflet tissue, calcified or cleft posterior leaflet) 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 provide signed 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 (3)

St. Johannes Hospital

Dortmund, Germany

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Laura A Brenton

  Polares Medical

  STUDY DIRECTOR

• Ulrich Schaefer, MD

  MarienKrankenhaus & Asklepios Klinik St. Georg, Hamburg (DE)

  PRINCIPAL INVESTIGATOR

• Stephan Windecker, MD

  Inselspital Bern, Bern (CH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 23, 2019
• Study Start: January 1, 2020
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: December 18, 2023

Record last verified: 2022-02

Locations

CH (2); DE (1)