A Clinical Evaluation of the Safety and Effectiveness of the MitraClip System in the Treatment of Clinically Significant Functional Mitral Regurgitation

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    650
  • sponsor
    Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
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Updated on 30 June 2021
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ejection fraction
regurgitation
heart failure
diuretics
nt-probnp
MRI
functional mitral regurgitation
blood pool scan

Summary

To study the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with New York Heart Association (NYHA) Functional Class II to Class IV chronic heart failure.

Description

The trial is designed to provide additional evidence regarding appropriate recommendations for use of the MitraClip System for patients with chronic heart failure and clinically significant functional mitral regurgitation. Additionally, the trial will collect evidence regarding health economics of the MitraClip System for use in this patient population.

Details
Condition Mitral Valve Regurgitation, mitral valve insufficiency, VALVULAR HEART DISEASE, Heart Valve Disease, mitral insufficiency, Mitral Regurgitation
Treatment Standard of Care, MITRACLIP
Clinical Study IdentifierNCT02444338
SponsorInstitut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Last Modified on30 June 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Clinically significant functional mitral regurgitation (moderate-to-severe or severe MR) as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Note: The TTE must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
Assessed by the investigator to be on optimal standard of care therapy for heart failure, according to current ESC/HFA guidelines with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization
Symptomatic with documented New York Heart Association Class II, III or IV heart failure, despite optimal standard of care therapy, within 30 days preceding randomization
Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of 300 pg/mL for BNP or 1000 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
Left ventricular ejection fraction (LVEF) of 15% to 35% (if in NYHA Functional Class II) or of 15% to 45% (if in NYHA Functional Class III or IV)
Note: LVEF needs to be determined by one of the following methods
transthoracic echocardiography (TTE), contrast ventriculography, gated blood
pool scan, cardiac magnetic resonance) within 90 days prior to randomization
Patient is ambulatory and able to perform a 6MWT with the only limiting factor(s) being due to cardiovascular fitness

Exclusion Criteria

Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative MR) as determined by transesophageal echocardiography (TEE)
Status 1 heart transplant or prior orthotropic heart transplantation
Introduction of a new heart failure drug class within the last 2 weeks prior to randomization
Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization
Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery, or atrial fibrillation ablation within 90 days prior to randomization
Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD)) within 90 day prior to randomization, or revision of any implanted rhythm management device within 90 days prior to randomization
Need for any cardiovascular surgery
Mitral valve surgery is considered the preferred therapeutic option for the subject
Renal replacement therapy
-Minute Walk Test (6MWT) distance > 475 meters
Mitral Valve Area (MVA) by planimetry < 4.0 cm2; if MVA by planimetry is not measurable, pressure half-time measurement is acceptable; MVA must be confirmed by the Echocardiography Core Laboratory
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