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Status:

TERMINATED

Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Mitral Regurgitation

Lead Sponsor:

Polares Medical SA

Conditions:

Mitral Regurgitation

Mitral Valve Disease

Eligibility:

All Genders

18+ years

Brief Summary

Early feasibility study, single-arm registry design

Detailed Description

First-In-Human

Eligibility Criteria

Inclusion

  • 18 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

Exclusion

  • 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

Key Trial Info

Start Date :

January 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 2 2023

Estimated Enrollment :

2 Patients enrolled

Trial Details

Trial ID

NCT04098328

Start Date

January 1 2020

End Date

February 2 2023

Last Update

December 18 2023

Active Locations (3)

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Page 1 of 1 (3 locations)

1

St. Johannes Hospital

Dortmund, Germany

2

Inselspital Bern

Bern, Switzerland, 3010

3

Luzerner Kantonsspital

Lucerne, Switzerland