Cardioband With Transfemoral Delivery System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2013 by Valtech Cardio Ltd.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Valtech Cardio Ltd Identifier:
First received: April 23, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted

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
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: 30
Study Start Date: April 2013
Estimated Primary Completion Date: October 2014 (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 to 80 Years
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
  Contacts and Locations
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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         
Asklepios Klinik, St. Georg Not yet recruiting
Hamburg, Germany, 5 20099
Contact: Karl-Heinz Kuck, Prof         
Contact    +49401818852305      
Principal Investigator: Karl-Heinz Kuck, Prof         
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: April 23, 2013
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 May 21, 2015