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Cardioband With Transfemoral Delivery System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Valtech Cardio Ltd
ClinicalTrials.gov Identifier:
NCT01841554
First received: April 23, 2013
Last updated: August 28, 2016
Last verified: August 2016
  Purpose
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: 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.


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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01841554

Locations
France
Bichat hospital
Paris, France, 18 75877
Germany
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
Netherlands
St.Antoniusziekenhuis
Nieuwegein, Netherlands
Switzerland
UniversitätsSpital Zürich
Zurich, Switzerland
Sponsors and Collaborators
Valtech Cardio Ltd
  More Information

Publications:
Responsible Party: Valtech Cardio Ltd
ClinicalTrials.gov Identifier: NCT01841554     History of Changes
Other Study ID Numbers: CB1-2 
Study First Received: April 23, 2013
Last Updated: August 28, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Valtech Cardio Ltd:
Mitral Valve
Annuloplasty

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 02, 2016