This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Cardioband With Transfemoral Delivery System

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Valtech Cardio Ltd Identifier:
First received: April 23, 2013
Last updated: August 28, 2016
Last verified: August 2016
To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.

Condition Intervention
Mitral Regurgitation Device: Cardioband

Study Type: Interventional
Study Design: 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

Further study details as provided by Valtech Cardio Ltd:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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.

Enrollment: 51
Study Start Date: April 2013
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Device: Cardioband
Other Name: With Transfemoral delivery system


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01841554

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
Valtech Cardio Ltd
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Valtech Cardio Ltd Identifier: NCT01841554     History of Changes
Other Study ID Numbers: CB1-2
Study First Received: April 23, 2013
Last Updated: August 28, 2016

Keywords provided by Valtech Cardio Ltd:
Mitral Valve

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases processed this record on August 23, 2017