Cardioband With Transfemoral Delivery System

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Valtech Cardio Ltd
Information provided by (Responsible Party):
Valtech Cardio Ltd Identifier:
First received: April 23, 2013
Last updated: June 14, 2015
Last verified: June 2015

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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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.

Estimated Enrollment: 45
Study Start Date: April 2013
Estimated Primary Completion Date: October 2015 (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
Genders Eligible for Study:   Both
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 Recruiting
Paris, France, 18 75877
Contact: Alec Vahanian, MD    +33140256735/60      
Principal Investigator: Alec Vahanian, Prof         
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II Recruiting
Bonn, Germany, 53105
Contact: Georg Nickenig, Prof.   
Principal Investigator: Georg Nickenig, Prof.         
CardioVasculäres Centrum Frankfurt Not yet recruiting
Frankfurt, Germany, 60389
Contact: Sievert Horst, Prof   
Principal Investigator: Sievert Horst, Prof.         
Asklepios Klinik, St. Georg Recruiting
Hamburg, Germany, 5 20099
Contact: Karl-Heinz Kuck, Prof   
Contact    +49401818852305      
Principal Investigator: Karl-Heinz Kuck, Prof         
Medizinisches Versorgungszentrum, Hamburg Not yet recruiting
Hamburg, Germany, D-22527
Contact: Joachim Schofer, Prof.   
Principal Investigator: Joachim Schofer, Prof.         
Universitätskliniken zu Köln Klinik III Innere Medizin Recruiting
Köln, Germany, 50937
Contact: Stephan Baldus, Prof.    49 221 478 32511      
Principal Investigator: Stephan Baldus, Prof.         
St.Antoniusziekenhuis Not yet recruiting
Nieuwegein, Netherlands
Contact: Jan van der Heijden, Dr    31883203000      
Principal Investigator: Jan van der Heijden, Dr.         
UniversitätsSpital Zürich Recruiting
Zurich, Switzerland
Contact: Oliver Gaemperli, Dr.    +41 (0)44 255 11 11      
Principal Investigator: Oliver Gaemperli, Dr.         
Sponsors and Collaborators
Valtech Cardio Ltd
  More Information

No publications provided

Responsible Party: Valtech Cardio Ltd Identifier: NCT01841554     History of Changes
Other Study ID Numbers: CB1-2
Study First Received: April 23, 2013
Last Updated: June 14, 2015
Health Authority: France:ANSM

Keywords provided by Valtech Cardio Ltd:
Mitral Valve

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases processed this record on October 09, 2015