Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Valtech Cardio Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Valtech Cardio Ltd
ClinicalTrials.gov Identifier:
NCT01533883
First received: February 7, 2012
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a minimally invasive (transatrial, transapical or transfemoral) procedure. The aim of this study is to evaluate the performance and safety of the Cardioband for transatrial repair of mitral regurgitation.


Condition Intervention
Mitral Valve Insufficiency
Device: Cardioband adjustable band

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair

Further study details as provided by Valtech Cardio Ltd:

Primary Outcome Measures:
  • safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Overall rate of Serious adverse events (SAEs) and serious adverse device effects (SADE) until hospital discharge and at post-operative 30 days.

  • Technical success rate of the implantation of the Cardioband [ Time Frame: Immedietly after implantation ] [ Designated as safety issue: No ]
  • Technical feasibility of Cardioband adjustment [ Time Frame: Immedietly after procedure ] [ Designated as safety issue: No ]
  • Reduce MR [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Cardioband ability to reduce mitral valve regurgitation (MR) post-procedure, at post-operative hospital discharge, and at post-operative 30 days.


Secondary Outcome Measures:
  • safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Overall rate of Serious adverse events (SAEs) and serious adverse device effects (SADE)will be compared to the literature.


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Cardioband adjustable band
    Cardioband is an adjustable sutureless annuloplasty band designed for mitral valve repair by a minimally invasive (transatrial, transapical or transfemoral) procedure. Cardioband is intended to remodel the annulus by deployment and fixation along the posterior annulus of the mitral valve, in order to correct mitral regurgitation. Adjustment can be performed on a beating heart, to optimize correction of mitral regurgitation.
Detailed Description:

The current state of the art management of severe mitral regurgitation is surgical mitral valve repair, either with open chest surgery or mini-thoracotomy. However, standard surgical approaches requiring cardiopulmonary bypass are reserved to fit patients with low or moderate surgical risk, and thus several patients are refused surgery because of unfavorable risk-benefit balance.Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a minimally invasive (transatrial, transapical or transfemoral) procedure. Cardioband is intended to remodel the annulus by deployment and fixation along (and direct) the posterior annulus of the mitral valve, in order to correct mitral regurgitation. Adjustment can be performed on a beating heart, to optimize correction of mitral regurgitation.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient is a candidate for mitral valve repair: moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction (AHA/ACC criteria)

Criteria

Inclusion Criteria:

  • Age > 18 years
  • Patient is a candidate for mitral valve repair: moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction (AHA/ACC criteria)
  • Patients qualify for mitral valve surgery including cardiopulmonary bypass
  • Patient able and willing to return to the implant centre for follow-up visits.
  • Able and willing to give informed consent and follow protocol procedures.

Exclusion Criteria:

  • Severe organic lesions with mitral chords retraction, severely fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
  • Evolving endocarditis or active endocarditis in the last 3 months.
  • Heavily calcified annulus or leaflets.
  • Congenital malformation with limited valvular tissue
  • Patient requires mitral valve replacement
  • Previously implanted prosthetic mitral valve or annuloplasty ring/band.
  • Patients in whom transesophageal echocardiography is contraindicated.
  • Patient is pregnant (urine HCG test result positive) or lactating.
  • Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.
  • Life expectancy of less than twelve months.
  • Patient is participating in concomitant research studies of investigational products.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533883

Contacts
Contact: Francesco Maisano, MD 39-02-26437111 francesco.maisano@hsr.it

Locations
Italy
Hospital san raffaele Recruiting
Milano, Italy, 20132
Contact: Ottavio Alfieri, MD         
Contact: Francesco Maisano, MD         
Principal Investigator: Michael Borger, MD, PhD         
Sponsors and Collaborators
Valtech Cardio Ltd
Investigators
Principal Investigator: Ottavio Alfieri, MD Hospital San Raffaele, Milan, Italy
Principal Investigator: Michael Borger, MD PhD Heart Center Leipzig, Leipzig, Germany
  More Information

No publications provided

Responsible Party: Valtech Cardio Ltd
ClinicalTrials.gov Identifier: NCT01533883     History of Changes
Other Study ID Numbers: CB1-1
Study First Received: February 7, 2012
Last Updated: February 15, 2012
Health Authority: Italy: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Valtech Cardio Ltd:
Mitral
Valve
Annuloplasty
Transatrial
Transapical
Transfemoral
Mitral valve insufficiency

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

ClinicalTrials.gov processed this record on April 14, 2014