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Cardioband With Transfemoral Delivery System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01841554
Recruitment Status : Unknown
Verified August 2016 by Edwards Lifesciences.
Recruitment status was:  Active, not recruiting
First Posted : April 26, 2013
Last Update Posted : August 30, 2016
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Device: Cardioband Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation
Study Start Date : April 2013
Actual Primary Completion Date : July 2016

Arm Intervention/treatment
Experimental: Single Device: Cardioband
Other Name: With Transfemoral delivery system

Primary Outcome Measures :
  1. Safety • Overall rate of Major Serious Adverse Events (SAEs) and serious adverse safety [ Time Frame: 30 days ]

    Overall rate of Major Serious Adverse Events (SAEs)* and serious adverse device effects (SADE) until hospital discharge and at post-operative 30 days.

    * Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke

Secondary Outcome Measures :
  1. Performance [ Time Frame: up to 12 months ]
    • MR Severity at 6 and 12 months
    • Change in 6 MWT in 6 and 12 months
    • Change in quality of life (MLHFQ) at 6 and 12 months

Other Outcome Measures:
  1. Performance [ Time Frame: 30 days ]
    • Technical success rate of the implantation of the Cardioband
    • Technical feasibility of Cardioband adjustment
    • Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years
  • Moderate to severe functional MR
  • Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including CRT if indicated.
  • LVEF ≥ 25%, LVEDD ≤ 65mm
  • Subject is high risk to undergo MV surgery (as assessed by a surgeon and a cardiologist, at the site)
  • Transseptal catheterization and femoral vein access is determined to be feasible
  • Subject is able and willing to give informed consent and follow protocol procedures

Exclusion Criteria:

  • Active bacterial endocarditis
  • Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue
  • Heavily calcified annulus or leaflets
  • Subjects in whom transesophageal echocardiography is contraindicated
  • Untreated clinically significant CAD requiring revascularization
  • CRT implant within 3 months prior to procedure
  • Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
  • CVA or TIA within 6 months or severe carotid stenosis (>70% by Ultra sound)
  • Renal insufficiency requiring dialysis
  • Life expectancy of less than twelve months
  • Subject is participating in concomitant research studies of investigational products
  • Mitral valve anatomy which may preclude proper device treatment
  • Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01841554

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Bichat hospital
Paris, France, 18 75877
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II
Bonn, Germany, 53105
CardioVasculäres Centrum Frankfurt
Frankfurt, Germany, 60389
Asklepios Klinik, St. Georg
Hamburg, Germany, 5 20099
Medizinisches Versorgungszentrum, Hamburg
Hamburg, Germany, D-22527
Universitätskliniken zu Köln Klinik III Innere Medizin
Köln, Germany, 50937
Nieuwegein, Netherlands
UniversitätsSpital Zürich
Zurich, Switzerland
Sponsors and Collaborators
Edwards Lifesciences

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Edwards Lifesciences Identifier: NCT01841554    
Obsolete Identifiers: NCT01533883
Other Study ID Numbers: CB1-2
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Keywords provided by Edwards Lifesciences:
Mitral Valve
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases